Trial Outcomes & Findings for Myofunctional Training for Obstructive Sleep Apnea Patients After Transoral Robotic Surgery (NCT NCT04876482)
NCT ID: NCT04876482
Last Updated: 2024-10-21
Results Overview
Polysomnography included electroencephalographic, electro-oculographic, thoracic and abdominal respiratory inductance plethysmography and body position sensor to confirm the sleeping stage in one-night observation. Above measurements will be aggregated to arrive AHI. Unabbreviated scale title:Apnea and Hypopnea index The minimum value:0 The maximum values: none Higher scores mean a worse outcome.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
81 participants
Primary outcome timeframe
through study completion, an average of 6 months
Results posted on
2024-10-21
Participant Flow
Recruited time:2020/01/01-2022/05/11
Participant milestones
| Measure |
Control
Without the willingness of surgery, those participants waiting for oral appliance (Device), losing weights and using continuous positive airway pressure (Device) were distribute to control group.
oral appliance: It is a kind of treatment for the participants who refuse surgeries and choose to use other kinds of conservative treatment. The conservative treatments included oral appliance, losing weights and using continuous positive airway pressure. The oral appliance would be wore only at night and it would press the soft palate and protrude the jaw.
using continuous positive airway pressure: The participants only used CPAP at night. The device composed of a main machine, pipe and mask. The participants would instruct to wore the mask. The main machine would give positive airway pressure to open the airway and avoid collapsing.
losing weights: The participants would ask to lose weight by changing their diets and exercising, without using drugs and surgeries.
|
Transoral Robotic Surgery (TORS)
The participants underwent TORS. TORS is a kind of surgery that the surgeons would remove the tonsils and the fat tissue of tongue base and suspend the soft palate.
transoral robotic surgery: transoral robotic surgery (TORS) which remove the extra soft tissue of the base of the tongue and soft palate in this study
|
TORS+OPR
The participants started OPR 6 weeks after TORS. Each exercise was repeated 10 times, 1-3 cycles per day, 3-5 sessions per week at their home and performed for 3 months. Patients were supervised by physical therapist once a week for 30 minutes.
transoral robotic surgery: transoral robotic surgery (TORS) which remove the extra soft tissue of the base of the tongue and soft palate in this study
oropharyngeal rehabilitation: OPR included exercise for soft palate, tongue and oropharynx. There are 13 movements in OPR. The movements would be teach by a physical therapist.
|
|---|---|---|---|
|
Overall Study
STARTED
|
20
|
42
|
19
|
|
Overall Study
COMPLETED
|
17
|
38
|
19
|
|
Overall Study
NOT COMPLETED
|
3
|
4
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Myofunctional Training for Obstructive Sleep Apnea Patients After Transoral Robotic Surgery
Baseline characteristics by cohort
| Measure |
Control
n=20 Participants
Without the willingness of surgery, those participants waiting for oral appliance (Device), losing weights and using continuous positive airway pressure (Device) were distribute to control group.
oral appliance: It is a kind of treatment for the participants who refuse surgeries and choose to use other kinds of conservative treatment. The conservative treatments included oral appliance, losing weights and using continuous positive airway pressure. The oral appliance would be wore only at night and it would press the soft palate and protrude the jaw.
using continuous positive airway pressure: The participants only used CPAP at night. The device composed of a main machine, pipe and mask. The participants would instruct to wore the mask. The main machine would give positive airway pressure to open the airway and avoid collapsing.
losing weights: The participants would ask to lose weight by changing their diets and exercising, without using drugs and surgeries.
|
Transoral Robotic Surgery (TORS)
n=42 Participants
The participants underwent TORS. TORS is a kind of surgery that the surgeons would remove the tonsils and the fat tissue of tongue base and suspend the soft palate.
transoral robotic surgery: transoral robotic surgery (TORS) which remove the extra soft tissue of the base of the tongue and soft palate in this study
|
TORS+OPR
n=19 Participants
The participants started OPR 6 weeks after TORS. Each exercise was repeated 10 times, 1-3 cycles per day, 3-5 sessions per week at their home and performed for 3 months. Patients were supervised by physical therapist once a week for 30 minutes.
transoral robotic surgery: transoral robotic surgery (TORS) which remove the extra soft tissue of the base of the tongue and soft palate in this study
oropharyngeal rehabilitation: OPR included exercise for soft palate, tongue and oropharynx. There are 13 movements in OPR. The movements would be teach by a physical therapist.
|
Total
n=81 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
81 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Continuous
|
44.25 years
STANDARD_DEVIATION 9.55 • n=5 Participants
|
43.12 years
STANDARD_DEVIATION 10.87 • n=7 Participants
|
45.10 years
STANDARD_DEVIATION 8.63 • n=5 Participants
|
43.91 years
STANDARD_DEVIATION 9.93 • n=4 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
70 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
20 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
81 Participants
n=4 Participants
|
|
Region of Enrollment
Taiwan
|
20 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
81 Participants
n=4 Participants
|
|
Polysomonography
|
38.39 events per hour
STANDARD_DEVIATION 22.15 • n=5 Participants
|
43.98 events per hour
STANDARD_DEVIATION 19.86 • n=7 Participants
|
45.43 events per hour
STANDARD_DEVIATION 21.71 • n=5 Participants
|
42.92 events per hour
STANDARD_DEVIATION 20.86 • n=4 Participants
|
|
Body mass index
|
27.11 kg/m^2
STANDARD_DEVIATION 3.48 • n=5 Participants
|
28.09 kg/m^2
STANDARD_DEVIATION 3.72 • n=7 Participants
|
27.31 kg/m^2
STANDARD_DEVIATION 4.18 • n=5 Participants
|
27.62 kg/m^2
STANDARD_DEVIATION 3.76 • n=4 Participants
|
|
Neck circumference
|
37.81 cm
STANDARD_DEVIATION 2.53 • n=5 Participants
|
39.38 cm
STANDARD_DEVIATION 3.48 • n=7 Participants
|
39.53 cm
STANDARD_DEVIATION 2.08 • n=5 Participants
|
39.00 cm
STANDARD_DEVIATION 2.98 • n=4 Participants
|
|
Tongue protrusion muscle strength
|
52.50 kPa
STANDARD_DEVIATION 12.82 • n=5 Participants
|
61.16 kPa
STANDARD_DEVIATION 16.94 • n=7 Participants
|
51.00 kPa
STANDARD_DEVIATION 15.87 • n=5 Participants
|
56.10 kPa
STANDARD_DEVIATION 16.17 • n=4 Participants
|
|
Tongue elevation muscle strength
|
52.50 kPa
STANDARD_DEVIATION 14.13 • n=5 Participants
|
58.25 kPa
STANDARD_DEVIATION 15.25 • n=7 Participants
|
50.47 kPa
STANDARD_DEVIATION 10.52 • n=5 Participants
|
54.61 kPa
STANDARD_DEVIATION 14.05 • n=4 Participants
|
|
Tongue depression muscle strength
|
43.56 kPa
STANDARD_DEVIATION 10.19 • n=5 Participants
|
47.16 kPa
STANDARD_DEVIATION 11.04 • n=7 Participants
|
40.95 kPa
STANDARD_DEVIATION 10.86 • n=5 Participants
|
44.51 kPa
STANDARD_DEVIATION 10.95 • n=4 Participants
|
|
Tongue lateralization muscle strength
|
35.72 kPa
STANDARD_DEVIATION 9.98 • n=5 Participants
|
42.20 kPa
STANDARD_DEVIATION 11.81 • n=7 Participants
|
41.79 kPa
STANDARD_DEVIATION 11.45 • n=5 Participants
|
40.40 kPa
STANDARD_DEVIATION 11.44 • n=4 Participants
|
|
Computed Tomography_ Volume
|
19.04 cm^3
STANDARD_DEVIATION 11.40 • n=5 Participants
|
19.33 cm^3
STANDARD_DEVIATION 8.67 • n=7 Participants
|
16.80 cm^3
STANDARD_DEVIATION 6.07 • n=5 Participants
|
18.56 cm^3
STANDARD_DEVIATION 8.82 • n=4 Participants
|
|
Computed Tomography_ minimal area
|
3.71 cm^2
STANDARD_DEVIATION 1.94 • n=5 Participants
|
3.88 cm^2
STANDARD_DEVIATION 1.44 • n=7 Participants
|
3.54 cm^2
STANDARD_DEVIATION 1.38 • n=5 Participants
|
3.74 cm^2
STANDARD_DEVIATION 1.55 • n=4 Participants
|
|
Computed Tomography_ AP distance
|
1.72 cm
STANDARD_DEVIATION 0.77 • n=5 Participants
|
1.70 cm
STANDARD_DEVIATION 0.49 • n=7 Participants
|
1.66 cm
STANDARD_DEVIATION 0.40 • n=5 Participants
|
1.69 cm
STANDARD_DEVIATION 0.55 • n=4 Participants
|
|
Computed Tomography_ lateral distance distance
|
3.02 cm
STANDARD_DEVIATION 0.84 • n=5 Participants
|
3.30 cm
STANDARD_DEVIATION 0.74 • n=7 Participants
|
3.22 cm
STANDARD_DEVIATION 0.51 • n=5 Participants
|
3.20 cm
STANDARD_DEVIATION 0.71 • n=4 Participants
|
|
Drug-induced sleep endoscopy
|
20 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
81 Participants
n=4 Participants
|
|
Jaw opening muscle strength
|
8.97 kg
STANDARD_DEVIATION 3.70 • n=5 Participants
|
9.70 kg
STANDARD_DEVIATION 3.87 • n=7 Participants
|
9.84 kg
STANDARD_DEVIATION 2.52 • n=5 Participants
|
9.55 kg
STANDARD_DEVIATION 3.47 • n=4 Participants
|
PRIMARY outcome
Timeframe: through study completion, an average of 6 monthsPopulation: Seven participants didn't complete the whole protocol, so we didn't analyze their data.
Polysomnography included electroencephalographic, electro-oculographic, thoracic and abdominal respiratory inductance plethysmography and body position sensor to confirm the sleeping stage in one-night observation. Above measurements will be aggregated to arrive AHI. Unabbreviated scale title:Apnea and Hypopnea index The minimum value:0 The maximum values: none Higher scores mean a worse outcome.
Outcome measures
| Measure |
Control
n=17 Participants
Without the willingness of surgery, those participants waiting for oral appliance (Device), losing weights and using continuous positive airway pressure (Device) were distribute to control group.
oral appliance: It is a kind of treatment for the participants who refuse surgeries and choose to use other kinds of conservative treatment. The conservative treatments included oral appliance, losing weights and using continuous positive airway pressure. The oral appliance would be wore only at night and it would press the soft palate and protrude the jaw.
using continuous positive airway pressure: The participants only used CPAP at night. The device composed of a main machine, pipe and mask. The participants would instruct to wore the mask. The main machine would give positive airway pressure to open the airway and avoid collapsing.
losing weights: The participants would ask to lose weight by changing their diets and exercising, without using drugs and surgeries.
|
Transoral Robotic Surgery (TORS)
n=38 Participants
The participants underwent TORS. TORS is a kind of surgery that the surgeons would remove the tonsils and the fat tissue of tongue base and suspend the soft palate.
transoral robotic surgery: transoral robotic surgery (TORS) which remove the extra soft tissue of the base of the tongue and soft palate in this study
|
TORS+OPR
n=19 Participants
The participants started OPR 6 weeks after TORS. Each exercise was repeated 10 times, 1-3 cycles per day, 3-5 sessions per week at their home and performed for 3 months. Patients were supervised by physical therapist once a week for 30 minutes.
transoral robotic surgery: transoral robotic surgery (TORS) which remove the extra soft tissue of the base of the tongue and soft palate in this study
oropharyngeal rehabilitation: OPR included exercise for soft palate, tongue and oropharynx. There are 13 movements in OPR. The movements would be teach by a physical therapist.
|
|---|---|---|---|
|
Apnea Hypopnea Index (AHI)
|
44.89 events per hour
Standard Deviation 21.09
|
44.65 events per hour
Standard Deviation 19.91
|
36.87 events per hour
Standard Deviation 21.87
|
PRIMARY outcome
Timeframe: through study completion, an average of 6 monthsPopulation: Seven participants didn't complete the whole protocol, so we didn't analyze their data.
All patients underwent CT in a supine position. Each patient was instructed to maintain his/her tongue in the resting position, without swallowing, during CT. Volume from hard palate to the base of epiglottis was measured.
Outcome measures
| Measure |
Control
n=17 Participants
Without the willingness of surgery, those participants waiting for oral appliance (Device), losing weights and using continuous positive airway pressure (Device) were distribute to control group.
oral appliance: It is a kind of treatment for the participants who refuse surgeries and choose to use other kinds of conservative treatment. The conservative treatments included oral appliance, losing weights and using continuous positive airway pressure. The oral appliance would be wore only at night and it would press the soft palate and protrude the jaw.
using continuous positive airway pressure: The participants only used CPAP at night. The device composed of a main machine, pipe and mask. The participants would instruct to wore the mask. The main machine would give positive airway pressure to open the airway and avoid collapsing.
losing weights: The participants would ask to lose weight by changing their diets and exercising, without using drugs and surgeries.
|
Transoral Robotic Surgery (TORS)
n=38 Participants
The participants underwent TORS. TORS is a kind of surgery that the surgeons would remove the tonsils and the fat tissue of tongue base and suspend the soft palate.
transoral robotic surgery: transoral robotic surgery (TORS) which remove the extra soft tissue of the base of the tongue and soft palate in this study
|
TORS+OPR
n=19 Participants
The participants started OPR 6 weeks after TORS. Each exercise was repeated 10 times, 1-3 cycles per day, 3-5 sessions per week at their home and performed for 3 months. Patients were supervised by physical therapist once a week for 30 minutes.
transoral robotic surgery: transoral robotic surgery (TORS) which remove the extra soft tissue of the base of the tongue and soft palate in this study
oropharyngeal rehabilitation: OPR included exercise for soft palate, tongue and oropharynx. There are 13 movements in OPR. The movements would be teach by a physical therapist.
|
|---|---|---|---|
|
Computer Tomography (CT)_Volume
|
18.39 cm^3
Standard Deviation 11.47
|
18.72 cm^3
Standard Deviation 6.43
|
16.80 cm^3
Standard Deviation 6.07
|
PRIMARY outcome
Timeframe: through study completion, an average of 6 monthsPopulation: Seven participants didn't complete the whole protocol, so we didn't analyze their data.
All patients underwent CT in a supine position. Each patient was instructed to maintain his/her tongue in the resting position, without swallowing, during CT. Cross section area on the tip of epiglottis was measured.
Outcome measures
| Measure |
Control
n=17 Participants
Without the willingness of surgery, those participants waiting for oral appliance (Device), losing weights and using continuous positive airway pressure (Device) were distribute to control group.
oral appliance: It is a kind of treatment for the participants who refuse surgeries and choose to use other kinds of conservative treatment. The conservative treatments included oral appliance, losing weights and using continuous positive airway pressure. The oral appliance would be wore only at night and it would press the soft palate and protrude the jaw.
using continuous positive airway pressure: The participants only used CPAP at night. The device composed of a main machine, pipe and mask. The participants would instruct to wore the mask. The main machine would give positive airway pressure to open the airway and avoid collapsing.
losing weights: The participants would ask to lose weight by changing their diets and exercising, without using drugs and surgeries.
|
Transoral Robotic Surgery (TORS)
n=42 Participants
The participants underwent TORS. TORS is a kind of surgery that the surgeons would remove the tonsils and the fat tissue of tongue base and suspend the soft palate.
transoral robotic surgery: transoral robotic surgery (TORS) which remove the extra soft tissue of the base of the tongue and soft palate in this study
|
TORS+OPR
n=19 Participants
The participants started OPR 6 weeks after TORS. Each exercise was repeated 10 times, 1-3 cycles per day, 3-5 sessions per week at their home and performed for 3 months. Patients were supervised by physical therapist once a week for 30 minutes.
transoral robotic surgery: transoral robotic surgery (TORS) which remove the extra soft tissue of the base of the tongue and soft palate in this study
oropharyngeal rehabilitation: OPR included exercise for soft palate, tongue and oropharynx. There are 13 movements in OPR. The movements would be teach by a physical therapist.
|
|---|---|---|---|
|
Computer Tomography (CT)_minimal Area
|
3.60 cm^2
Standard Deviation 1.94
|
3.80 cm^2
Standard Deviation 1.13
|
3.54 cm^2
Standard Deviation 1.38
|
PRIMARY outcome
Timeframe: through study completion, an average of 6 monthsPopulation: Seven participants didn't complete the whole protocol, so we didn't analyze their data.
All patients underwent CT in a supine position. Each patient was instructed to maintain his/her tongue in the resting position, without swallowing, during CT. Anterior to posterior distance on the tip of epiglottis was measured.
Outcome measures
| Measure |
Control
n=17 Participants
Without the willingness of surgery, those participants waiting for oral appliance (Device), losing weights and using continuous positive airway pressure (Device) were distribute to control group.
oral appliance: It is a kind of treatment for the participants who refuse surgeries and choose to use other kinds of conservative treatment. The conservative treatments included oral appliance, losing weights and using continuous positive airway pressure. The oral appliance would be wore only at night and it would press the soft palate and protrude the jaw.
using continuous positive airway pressure: The participants only used CPAP at night. The device composed of a main machine, pipe and mask. The participants would instruct to wore the mask. The main machine would give positive airway pressure to open the airway and avoid collapsing.
losing weights: The participants would ask to lose weight by changing their diets and exercising, without using drugs and surgeries.
|
Transoral Robotic Surgery (TORS)
n=38 Participants
The participants underwent TORS. TORS is a kind of surgery that the surgeons would remove the tonsils and the fat tissue of tongue base and suspend the soft palate.
transoral robotic surgery: transoral robotic surgery (TORS) which remove the extra soft tissue of the base of the tongue and soft palate in this study
|
TORS+OPR
n=19 Participants
The participants started OPR 6 weeks after TORS. Each exercise was repeated 10 times, 1-3 cycles per day, 3-5 sessions per week at their home and performed for 3 months. Patients were supervised by physical therapist once a week for 30 minutes.
transoral robotic surgery: transoral robotic surgery (TORS) which remove the extra soft tissue of the base of the tongue and soft palate in this study
oropharyngeal rehabilitation: OPR included exercise for soft palate, tongue and oropharynx. There are 13 movements in OPR. The movements would be teach by a physical therapist.
|
|---|---|---|---|
|
Computer Tomography (CT)_AP Distance
|
1.71 cm
Standard Deviation 0.79
|
1.64 cm
Standard Deviation 0.39
|
1.66 cm
Standard Deviation 0.40
|
PRIMARY outcome
Timeframe: through study completion, an average of 6 monthsPopulation: Seven participants didn't complete the whole protocol, so we didn't analyze their data.
All patients underwent CT in a supine position. Each patient was instructed to maintain his/her tongue in the resting position, without swallowing, during CT. Lateral distance on the tip of epiglottis was measured.
Outcome measures
| Measure |
Control
n=17 Participants
Without the willingness of surgery, those participants waiting for oral appliance (Device), losing weights and using continuous positive airway pressure (Device) were distribute to control group.
oral appliance: It is a kind of treatment for the participants who refuse surgeries and choose to use other kinds of conservative treatment. The conservative treatments included oral appliance, losing weights and using continuous positive airway pressure. The oral appliance would be wore only at night and it would press the soft palate and protrude the jaw.
using continuous positive airway pressure: The participants only used CPAP at night. The device composed of a main machine, pipe and mask. The participants would instruct to wore the mask. The main machine would give positive airway pressure to open the airway and avoid collapsing.
losing weights: The participants would ask to lose weight by changing their diets and exercising, without using drugs and surgeries.
|
Transoral Robotic Surgery (TORS)
n=38 Participants
The participants underwent TORS. TORS is a kind of surgery that the surgeons would remove the tonsils and the fat tissue of tongue base and suspend the soft palate.
transoral robotic surgery: transoral robotic surgery (TORS) which remove the extra soft tissue of the base of the tongue and soft palate in this study
|
TORS+OPR
n=19 Participants
The participants started OPR 6 weeks after TORS. Each exercise was repeated 10 times, 1-3 cycles per day, 3-5 sessions per week at their home and performed for 3 months. Patients were supervised by physical therapist once a week for 30 minutes.
transoral robotic surgery: transoral robotic surgery (TORS) which remove the extra soft tissue of the base of the tongue and soft palate in this study
oropharyngeal rehabilitation: OPR included exercise for soft palate, tongue and oropharynx. There are 13 movements in OPR. The movements would be teach by a physical therapist.
|
|---|---|---|---|
|
Computer Tomography (CT)_Lateral Distance
|
2.92 cm
Standard Deviation 0.83
|
3.43 cm
Standard Deviation 0.63
|
3.22 cm
Standard Deviation 0.51
|
PRIMARY outcome
Timeframe: through study completion, an average of 6 monthsPopulation: Seven participants didn't complete the whole protocol, so we didn't analyze their data.
All patients underwent DISE in a supine position. The possible outcomes were unilevel collapse at the velum, oropharynx, tongue base, or epiglottis and multilevel collapse at any of these locations. The velum is the part of the upper airway at the level of the soft palate and uvula; the oropharynx is the pharyngeal portion at the level of the tonsils, above the tongue base. The tongue base was considered the retroglossal area; epiglottis was considered the pharyngeal region below the tongue base. The degree of obstruciton was diagnosed by an ear nose throat surgeon. The degree of obstruction ranged from 0 to 2. 0: no obstruction (\<50%); 1: partial obstruction (50-75%); 2: complete obstruction (\>75%).
Outcome measures
| Measure |
Control
n=17 Participants
Without the willingness of surgery, those participants waiting for oral appliance (Device), losing weights and using continuous positive airway pressure (Device) were distribute to control group.
oral appliance: It is a kind of treatment for the participants who refuse surgeries and choose to use other kinds of conservative treatment. The conservative treatments included oral appliance, losing weights and using continuous positive airway pressure. The oral appliance would be wore only at night and it would press the soft palate and protrude the jaw.
using continuous positive airway pressure: The participants only used CPAP at night. The device composed of a main machine, pipe and mask. The participants would instruct to wore the mask. The main machine would give positive airway pressure to open the airway and avoid collapsing.
losing weights: The participants would ask to lose weight by changing their diets and exercising, without using drugs and surgeries.
|
Transoral Robotic Surgery (TORS)
n=38 Participants
The participants underwent TORS. TORS is a kind of surgery that the surgeons would remove the tonsils and the fat tissue of tongue base and suspend the soft palate.
transoral robotic surgery: transoral robotic surgery (TORS) which remove the extra soft tissue of the base of the tongue and soft palate in this study
|
TORS+OPR
n=19 Participants
The participants started OPR 6 weeks after TORS. Each exercise was repeated 10 times, 1-3 cycles per day, 3-5 sessions per week at their home and performed for 3 months. Patients were supervised by physical therapist once a week for 30 minutes.
transoral robotic surgery: transoral robotic surgery (TORS) which remove the extra soft tissue of the base of the tongue and soft palate in this study
oropharyngeal rehabilitation: OPR included exercise for soft palate, tongue and oropharynx. There are 13 movements in OPR. The movements would be teach by a physical therapist.
|
|---|---|---|---|
|
Drug-induced Sleep Endoscopy (DISE)
The degree of obstruction in velum · no obstruction
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Drug-induced Sleep Endoscopy (DISE)
The degree of obstruction in velum · partial obstruction
|
9 Participants
|
6 Participants
|
7 Participants
|
|
Drug-induced Sleep Endoscopy (DISE)
The degree of obstruction in oropharynx · complete obstruction
|
2 Participants
|
8 Participants
|
5 Participants
|
|
Drug-induced Sleep Endoscopy (DISE)
The degree of obstruction in tongue base · partial obstruction
|
7 Participants
|
16 Participants
|
9 Participants
|
|
Drug-induced Sleep Endoscopy (DISE)
The degree of obstruction in tongue base · complete obstruction
|
10 Participants
|
22 Participants
|
9 Participants
|
|
Drug-induced Sleep Endoscopy (DISE)
The degree of obstruction in epiglottis · no obstruction
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Drug-induced Sleep Endoscopy (DISE)
The degree of obstruction in epiglottis · partial obstruction
|
6 Participants
|
18 Participants
|
11 Participants
|
|
Drug-induced Sleep Endoscopy (DISE)
The degree of obstruction in velum · complete obstruction
|
8 Participants
|
32 Participants
|
11 Participants
|
|
Drug-induced Sleep Endoscopy (DISE)
The degree of obstruction in oropharynx · no obstruction
|
2 Participants
|
2 Participants
|
1 Participants
|
|
Drug-induced Sleep Endoscopy (DISE)
The degree of obstruction in oropharynx · partial obstruction
|
13 Participants
|
28 Participants
|
13 Participants
|
|
Drug-induced Sleep Endoscopy (DISE)
The degree of obstruction in tongue base · no obstruction
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Drug-induced Sleep Endoscopy (DISE)
The degree of obstruction in epiglottis · complete obstruction
|
11 Participants
|
20 Participants
|
8 Participants
|
PRIMARY outcome
Timeframe: through study completion, an average of 6 monthsPopulation: Seven participants didn't complete the whole protocol, so we didn't analyze their data.
Muscle strength of jaw was measured with a 'handheld' dynamometer (MicroFET○R2, Hoggan Scientific, USA) mounted on an adapted ophthalmic examination frame, to avoid alterations in chin and head position and to ensure consistent compression.
Outcome measures
| Measure |
Control
n=17 Participants
Without the willingness of surgery, those participants waiting for oral appliance (Device), losing weights and using continuous positive airway pressure (Device) were distribute to control group.
oral appliance: It is a kind of treatment for the participants who refuse surgeries and choose to use other kinds of conservative treatment. The conservative treatments included oral appliance, losing weights and using continuous positive airway pressure. The oral appliance would be wore only at night and it would press the soft palate and protrude the jaw.
using continuous positive airway pressure: The participants only used CPAP at night. The device composed of a main machine, pipe and mask. The participants would instruct to wore the mask. The main machine would give positive airway pressure to open the airway and avoid collapsing.
losing weights: The participants would ask to lose weight by changing their diets and exercising, without using drugs and surgeries.
|
Transoral Robotic Surgery (TORS)
n=38 Participants
The participants underwent TORS. TORS is a kind of surgery that the surgeons would remove the tonsils and the fat tissue of tongue base and suspend the soft palate.
transoral robotic surgery: transoral robotic surgery (TORS) which remove the extra soft tissue of the base of the tongue and soft palate in this study
|
TORS+OPR
n=19 Participants
The participants started OPR 6 weeks after TORS. Each exercise was repeated 10 times, 1-3 cycles per day, 3-5 sessions per week at their home and performed for 3 months. Patients were supervised by physical therapist once a week for 30 minutes.
transoral robotic surgery: transoral robotic surgery (TORS) which remove the extra soft tissue of the base of the tongue and soft palate in this study
oropharyngeal rehabilitation: OPR included exercise for soft palate, tongue and oropharynx. There are 13 movements in OPR. The movements would be teach by a physical therapist.
|
|---|---|---|---|
|
Jaw Opening Muscle Strength
|
9.14 kilogram force
Standard Deviation 3.67
|
9.63 kilogram force
Standard Deviation 3.59
|
9.68 kilogram force
Standard Deviation 2.49
|
PRIMARY outcome
Timeframe: through study completion, an average of 6 monthsPopulation: Seven participants didn't complete the whole protocol, so we didn't analyze their data.
The muscle strength of the tongue was evaluated by the IOPI system, model 2.2 (Northwest, Co., LLC, Carnation, WA, USA).
Outcome measures
| Measure |
Control
n=17 Participants
Without the willingness of surgery, those participants waiting for oral appliance (Device), losing weights and using continuous positive airway pressure (Device) were distribute to control group.
oral appliance: It is a kind of treatment for the participants who refuse surgeries and choose to use other kinds of conservative treatment. The conservative treatments included oral appliance, losing weights and using continuous positive airway pressure. The oral appliance would be wore only at night and it would press the soft palate and protrude the jaw.
using continuous positive airway pressure: The participants only used CPAP at night. The device composed of a main machine, pipe and mask. The participants would instruct to wore the mask. The main machine would give positive airway pressure to open the airway and avoid collapsing.
losing weights: The participants would ask to lose weight by changing their diets and exercising, without using drugs and surgeries.
|
Transoral Robotic Surgery (TORS)
n=38 Participants
The participants underwent TORS. TORS is a kind of surgery that the surgeons would remove the tonsils and the fat tissue of tongue base and suspend the soft palate.
transoral robotic surgery: transoral robotic surgery (TORS) which remove the extra soft tissue of the base of the tongue and soft palate in this study
|
TORS+OPR
n=19 Participants
The participants started OPR 6 weeks after TORS. Each exercise was repeated 10 times, 1-3 cycles per day, 3-5 sessions per week at their home and performed for 3 months. Patients were supervised by physical therapist once a week for 30 minutes.
transoral robotic surgery: transoral robotic surgery (TORS) which remove the extra soft tissue of the base of the tongue and soft palate in this study
oropharyngeal rehabilitation: OPR included exercise for soft palate, tongue and oropharynx. There are 13 movements in OPR. The movements would be teach by a physical therapist.
|
|---|---|---|---|
|
Tongue Protrusion Muscle Strength
|
57.83 kilopascals
Standard Deviation 11.17
|
56.97 kilopascals
Standard Deviation 11.72
|
61.89 kilopascals
Standard Deviation 8.88
|
PRIMARY outcome
Timeframe: through study completion, an average of 6 monthsPopulation: Seven participants didn't complete the whole protocol, so we didn't analyze their data.
The muscle strength of the tongue was evaluated by the IOPI system, model 2.2 (Northwest, Co., LLC, Carnation, WA, USA).
Outcome measures
| Measure |
Control
n=17 Participants
Without the willingness of surgery, those participants waiting for oral appliance (Device), losing weights and using continuous positive airway pressure (Device) were distribute to control group.
oral appliance: It is a kind of treatment for the participants who refuse surgeries and choose to use other kinds of conservative treatment. The conservative treatments included oral appliance, losing weights and using continuous positive airway pressure. The oral appliance would be wore only at night and it would press the soft palate and protrude the jaw.
using continuous positive airway pressure: The participants only used CPAP at night. The device composed of a main machine, pipe and mask. The participants would instruct to wore the mask. The main machine would give positive airway pressure to open the airway and avoid collapsing.
losing weights: The participants would ask to lose weight by changing their diets and exercising, without using drugs and surgeries.
|
Transoral Robotic Surgery (TORS)
n=38 Participants
The participants underwent TORS. TORS is a kind of surgery that the surgeons would remove the tonsils and the fat tissue of tongue base and suspend the soft palate.
transoral robotic surgery: transoral robotic surgery (TORS) which remove the extra soft tissue of the base of the tongue and soft palate in this study
|
TORS+OPR
n=19 Participants
The participants started OPR 6 weeks after TORS. Each exercise was repeated 10 times, 1-3 cycles per day, 3-5 sessions per week at their home and performed for 3 months. Patients were supervised by physical therapist once a week for 30 minutes.
transoral robotic surgery: transoral robotic surgery (TORS) which remove the extra soft tissue of the base of the tongue and soft palate in this study
oropharyngeal rehabilitation: OPR included exercise for soft palate, tongue and oropharynx. There are 13 movements in OPR. The movements would be teach by a physical therapist.
|
|---|---|---|---|
|
Tongue Elevation Muscle Strength
|
59.17 kilopascals
Standard Deviation 13.64
|
57.22 kilopascals
Standard Deviation 12.59
|
63.37 kilopascals
Standard Deviation 12.07
|
PRIMARY outcome
Timeframe: through study completion, an average of 6 monthsPopulation: Seven participants didn't complete the whole protocol, so we didn't analyze their data.
The muscle strength of the tongue was evaluated by the IOPI system, model 2.2 (Northwest, Co., LLC, Carnation, WA, USA).
Outcome measures
| Measure |
Control
n=17 Participants
Without the willingness of surgery, those participants waiting for oral appliance (Device), losing weights and using continuous positive airway pressure (Device) were distribute to control group.
oral appliance: It is a kind of treatment for the participants who refuse surgeries and choose to use other kinds of conservative treatment. The conservative treatments included oral appliance, losing weights and using continuous positive airway pressure. The oral appliance would be wore only at night and it would press the soft palate and protrude the jaw.
using continuous positive airway pressure: The participants only used CPAP at night. The device composed of a main machine, pipe and mask. The participants would instruct to wore the mask. The main machine would give positive airway pressure to open the airway and avoid collapsing.
losing weights: The participants would ask to lose weight by changing their diets and exercising, without using drugs and surgeries.
|
Transoral Robotic Surgery (TORS)
n=38 Participants
The participants underwent TORS. TORS is a kind of surgery that the surgeons would remove the tonsils and the fat tissue of tongue base and suspend the soft palate.
transoral robotic surgery: transoral robotic surgery (TORS) which remove the extra soft tissue of the base of the tongue and soft palate in this study
|
TORS+OPR
n=19 Participants
The participants started OPR 6 weeks after TORS. Each exercise was repeated 10 times, 1-3 cycles per day, 3-5 sessions per week at their home and performed for 3 months. Patients were supervised by physical therapist once a week for 30 minutes.
transoral robotic surgery: transoral robotic surgery (TORS) which remove the extra soft tissue of the base of the tongue and soft palate in this study
oropharyngeal rehabilitation: OPR included exercise for soft palate, tongue and oropharynx. There are 13 movements in OPR. The movements would be teach by a physical therapist.
|
|---|---|---|---|
|
Tongue Depression Muscle Strength
|
49.94 kilopascals
Standard Deviation 10.22
|
48.22 kilopascals
Standard Deviation 10.38
|
58.58 kilopascals
Standard Deviation 9.16
|
PRIMARY outcome
Timeframe: through study completion, an average of 6 monthsPopulation: Seven participants didn't complete the whole protocol, so we didn't analyze their data.
The muscle strength of the tongue was evaluated by the IOPI system, model 2.2 (Northwest, Co., LLC, Carnation, WA, USA).
Outcome measures
| Measure |
Control
n=17 Participants
Without the willingness of surgery, those participants waiting for oral appliance (Device), losing weights and using continuous positive airway pressure (Device) were distribute to control group.
oral appliance: It is a kind of treatment for the participants who refuse surgeries and choose to use other kinds of conservative treatment. The conservative treatments included oral appliance, losing weights and using continuous positive airway pressure. The oral appliance would be wore only at night and it would press the soft palate and protrude the jaw.
using continuous positive airway pressure: The participants only used CPAP at night. The device composed of a main machine, pipe and mask. The participants would instruct to wore the mask. The main machine would give positive airway pressure to open the airway and avoid collapsing.
losing weights: The participants would ask to lose weight by changing their diets and exercising, without using drugs and surgeries.
|
Transoral Robotic Surgery (TORS)
n=38 Participants
The participants underwent TORS. TORS is a kind of surgery that the surgeons would remove the tonsils and the fat tissue of tongue base and suspend the soft palate.
transoral robotic surgery: transoral robotic surgery (TORS) which remove the extra soft tissue of the base of the tongue and soft palate in this study
|
TORS+OPR
n=19 Participants
The participants started OPR 6 weeks after TORS. Each exercise was repeated 10 times, 1-3 cycles per day, 3-5 sessions per week at their home and performed for 3 months. Patients were supervised by physical therapist once a week for 30 minutes.
transoral robotic surgery: transoral robotic surgery (TORS) which remove the extra soft tissue of the base of the tongue and soft palate in this study
oropharyngeal rehabilitation: OPR included exercise for soft palate, tongue and oropharynx. There are 13 movements in OPR. The movements would be teach by a physical therapist.
|
|---|---|---|---|
|
Tongue Lateralization Muscle Strength
|
42.19 kilopascals
Standard Deviation 10.52
|
41.55 kilopascals
Standard Deviation 9.86
|
50.11 kilopascals
Standard Deviation 9.38
|
Adverse Events
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Transoral Robotic Surgery (TORS)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
TORS+OPR
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Yi-Ju, Lai
Department of Physical Therapy, Shu-Zen Junior College of Medicine and Management, Kaohsiung, Taiwan
Phone: +886963123117
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place