Trial Outcomes & Findings for Effects of Myofunctional Therapy With an Application in Severe Apnea/Hypopnea Sleep Obstructive Syndrome (MTASSAOS) (NCT NCT04438785)
NCT ID: NCT04438785
Last Updated: 2021-02-11
Results Overview
Measurement of number of apneas or hypopneas recorded during the study per hour of sleep
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
40 participants
Primary outcome timeframe
Baseline and three months
Results posted on
2021-02-11
Participant Flow
Participant milestones
| Measure |
INTERVENTION (AirwayGym) GROUP
Patients newly diagnosed with severe OSAHS should perform muscle upper airway exercises using the AirwayGym app for 20 min a day for 90 days.
The intervention consists of myofunctional therapy (MT) using the AirwayGym app.: Intervention. Patient newly diagnosed with severe OSAHS should perform muscle upper airway exercises using the App AirwayGym 20 minutes a day during 90 days.
|
CONTROL GROUP
Patients newly diagnosed with severe OSAHS do no therapy for 90 days.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
18
|
10
|
|
Overall Study
NOT COMPLETED
|
2
|
10
|
Reasons for withdrawal
| Measure |
INTERVENTION (AirwayGym) GROUP
Patients newly diagnosed with severe OSAHS should perform muscle upper airway exercises using the AirwayGym app for 20 min a day for 90 days.
The intervention consists of myofunctional therapy (MT) using the AirwayGym app.: Intervention. Patient newly diagnosed with severe OSAHS should perform muscle upper airway exercises using the App AirwayGym 20 minutes a day during 90 days.
|
CONTROL GROUP
Patients newly diagnosed with severe OSAHS do no therapy for 90 days.
|
|---|---|---|
|
Overall Study
change of weight, give up intervention
|
2
|
10
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
INTERVENTION (AirwayGym) GROUP
n=18 Participants
Patients newly diagnosed with severe OSAHS should perform muscle upper airway exercises using the AirwayGym app for 20 min a day for 90 days.
The intervention consists of myofunctional therapy (MT) using the AirwayGym app.: Intervention. Patient newly diagnosed with severe OSAHS should perform muscle upper airway exercises using the App AirwayGym 20 minutes a day during 90 days.
|
CONTROL GROUP
n=10 Participants
Patients newly diagnosed with severe OSAHS do no therapy for 90 days.
|
Total
n=28 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.17 years
n=18 Participants
|
63.9 years
n=10 Participants
|
62.2 years
n=28 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=18 Participants
|
2 Participants
n=10 Participants
|
6 Participants
n=28 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=18 Participants
|
8 Participants
n=10 Participants
|
22 Participants
n=28 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
IOPI tongue strength (is the maximun strength obtained by contraction of genioglossus muscle)
|
39.83 kilopascals
n=18 Participants
|
42 kilopascals
n=10 Participants
|
41.3 kilopascals
n=28 Participants
|
|
IOPI Lip Strength (maximal lip strength measured with muscle buccinator)
|
27.8 kilopascals
n=18 Participants
|
28.1 kilopascals
n=10 Participants
|
27.95 kilopascals
n=28 Participants
|
PRIMARY outcome
Timeframe: Baseline and three monthsMeasurement of number of apneas or hypopneas recorded during the study per hour of sleep
Outcome measures
| Measure |
INTERVENTION (AirwayGym) GROUP
n=18 Participants
Patients newly diagnosed with severe OSAHS should perform muscle upper airway exercises using the AirwayGym app for 20 min a day for 90 days.
The intervention consists of myofunctional therapy (MT) using the AirwayGym app.: Intervention. Patient newly diagnosed with severe OSAHS should perform muscle upper airway exercises using the App AirwayGym 20 minutes a day during 90 days.
|
CONTROL GROUP
n=10 Participants
Patients newly diagnosed with severe OSAHS do no therapy for 90 days.
|
|---|---|---|
|
Apnea Hypopnea Index (AHI)
Apnea Hypopnea Index (BASELINE)
|
44.77 events per hour
Interval 33.84 to 55.69
|
47.36 events per hour
Interval 38.59 to 56.13
|
|
Apnea Hypopnea Index (AHI)
Apnea Hypopnea Index(AFTER 3 MONTHS)
|
20.88 events per hour
Interval 14.02 to 27.74
|
35 events per hour
Interval 31.2 to 38.7
|
PRIMARY outcome
Timeframe: Baseline and three monthsThe ODI is the number of times per hour of sleep that the blood oxygen level drops by a certain degree from baseline. Any respiratory event during sleep with a 3% drop in blood oxygen levels is counted towards the total. For example, a change from 95% to 92% would be an event that is counted toward the index's total.
Outcome measures
| Measure |
INTERVENTION (AirwayGym) GROUP
n=18 Participants
Patients newly diagnosed with severe OSAHS should perform muscle upper airway exercises using the AirwayGym app for 20 min a day for 90 days.
The intervention consists of myofunctional therapy (MT) using the AirwayGym app.: Intervention. Patient newly diagnosed with severe OSAHS should perform muscle upper airway exercises using the App AirwayGym 20 minutes a day during 90 days.
|
CONTROL GROUP
n=10 Participants
Patients newly diagnosed with severe OSAHS do no therapy for 90 days.
|
|---|---|---|
|
Evaluation of O2 Desaturation Index (ODI)
ODI (BASELINE)
|
36.31 events per hour
Interval 27.19 to 43.43
|
40.64 events per hour
Interval 29.46 to 51.81
|
|
Evaluation of O2 Desaturation Index (ODI)
ODI (AFTER 3 MONTHS
|
19.4 events per hour
Interval 12.9 to 25.98
|
32.03 events per hour
Interval 24.14 to 39.91
|
SECONDARY outcome
Timeframe: Baseline and three monthsThe IOPI objectively measures maximum tongue strength in kilopascals and represents the tone of the genioglossus muscles.
Outcome measures
| Measure |
INTERVENTION (AirwayGym) GROUP
n=18 Participants
Patients newly diagnosed with severe OSAHS should perform muscle upper airway exercises using the AirwayGym app for 20 min a day for 90 days.
The intervention consists of myofunctional therapy (MT) using the AirwayGym app.: Intervention. Patient newly diagnosed with severe OSAHS should perform muscle upper airway exercises using the App AirwayGym 20 minutes a day during 90 days.
|
CONTROL GROUP
n=10 Participants
Patients newly diagnosed with severe OSAHS do no therapy for 90 days.
|
|---|---|---|
|
Evaluation of Iowa Oral Performance Instrument (IOPI) Score
|
44.1 Kilopascals
Interval 39.5 to 48.8
|
31.3 Kilopascals
Interval 26.6 to 35.9
|
SECONDARY outcome
Timeframe: Baseline and three monthsThe IOPI objectively measures maximum lip strength in kilopascals and represents the tone of the buccinator muscles.
Outcome measures
| Measure |
INTERVENTION (AirwayGym) GROUP
n=18 Participants
Patients newly diagnosed with severe OSAHS should perform muscle upper airway exercises using the AirwayGym app for 20 min a day for 90 days.
The intervention consists of myofunctional therapy (MT) using the AirwayGym app.: Intervention. Patient newly diagnosed with severe OSAHS should perform muscle upper airway exercises using the App AirwayGym 20 minutes a day during 90 days.
|
CONTROL GROUP
n=10 Participants
Patients newly diagnosed with severe OSAHS do no therapy for 90 days.
|
|---|---|---|
|
Iowa Oral Performance Instrument Lip Strength
IOPI Lip BASELINE
|
27.89 kilopascals
Interval 24.16 to 32.47
|
28.1 kilopascals
Interval 23.7 to 32.5
|
|
Iowa Oral Performance Instrument Lip Strength
IOPI Lip AFTER 3 MONTHS
|
44.11 kilopascals
Interval 39.5 to 48.8
|
31.3 kilopascals
Interval 26.6 to 35.9
|
SECONDARY outcome
Timeframe: Baseline and three months.Gives an idea if there is an anatomical change or reduction in fat in the upper airway muscles after intervention .
Outcome measures
| Measure |
INTERVENTION (AirwayGym) GROUP
n=18 Participants
Patients newly diagnosed with severe OSAHS should perform muscle upper airway exercises using the AirwayGym app for 20 min a day for 90 days.
The intervention consists of myofunctional therapy (MT) using the AirwayGym app.: Intervention. Patient newly diagnosed with severe OSAHS should perform muscle upper airway exercises using the App AirwayGym 20 minutes a day during 90 days.
|
CONTROL GROUP
n=10 Participants
Patients newly diagnosed with severe OSAHS do no therapy for 90 days.
|
|---|---|---|
|
Neck Circumference (cm)
Neck Circumference BASE LINE (CM)
|
43.7 centimetres
Interval 41.03 to 46.4
|
43.7 centimetres
Interval 40.33 to 46.6
|
|
Neck Circumference (cm)
Neck Circumference 3 MONTHS (CM)
|
44.6 centimetres
Interval 42.12 to 47.2
|
43.5 centimetres
Interval 40.33 to 46.67
|
SECONDARY outcome
Timeframe: Baseline and three monthsGives an idea if there is an anatomical change or reduction of fat in the thorax muscles after intervention.
Outcome measures
| Measure |
INTERVENTION (AirwayGym) GROUP
n=18 Participants
Patients newly diagnosed with severe OSAHS should perform muscle upper airway exercises using the AirwayGym app for 20 min a day for 90 days.
The intervention consists of myofunctional therapy (MT) using the AirwayGym app.: Intervention. Patient newly diagnosed with severe OSAHS should perform muscle upper airway exercises using the App AirwayGym 20 minutes a day during 90 days.
|
CONTROL GROUP
n=10 Participants
Patients newly diagnosed with severe OSAHS do no therapy for 90 days.
|
|---|---|---|
|
Waist Circumference (cm)
Waist circumference after 3 months (cm)
|
108.84 centimetres
Interval 102.9 to 115.4
|
108.5 centimetres
Interval 96.9 to 120.1
|
|
Waist Circumference (cm)
Waist circumference baseline (cm)
|
109.2 centimetres
Interval 102.9 to 115.4
|
109.1 centimetres
Interval 97.5 to 120.6
|
SECONDARY outcome
Timeframe: Baseline and three monthsis a value derived from the mass (weight) and height of a person. The BMI is defined as the body mass in kilograms divided by the square of the body height in meters, and is expressed in units kg/m\^2 .
Outcome measures
| Measure |
INTERVENTION (AirwayGym) GROUP
n=18 Participants
Patients newly diagnosed with severe OSAHS should perform muscle upper airway exercises using the AirwayGym app for 20 min a day for 90 days.
The intervention consists of myofunctional therapy (MT) using the AirwayGym app.: Intervention. Patient newly diagnosed with severe OSAHS should perform muscle upper airway exercises using the App AirwayGym 20 minutes a day during 90 days.
|
CONTROL GROUP
n=10 Participants
Patients newly diagnosed with severe OSAHS do no therapy for 90 days.
|
|---|---|---|
|
Body Mass Index BMI
BMI BASELINE kg/m^2 .
|
28.9 kilograms/m^2
Interval 26.8 to 31.02
|
29.6 kilograms/m^2
Interval 27.1 to 32.08
|
|
Body Mass Index BMI
BMI AFTER 3 MONTHS kg/m^2 .
|
28.8 kilograms/m^2
Interval 26.7 to 30.8
|
29.6 kilograms/m^2
Interval 27.3 to 31.8
|
SECONDARY outcome
Timeframe: Baseline and three monthsA scale (0-24), obtained by self-administered questionnaire, that rates an individual's probability of falling asleep on a scale of increasing probability from 0 to 3 for eight different situations that people experience in their daily lives.
Outcome measures
| Measure |
INTERVENTION (AirwayGym) GROUP
n=18 Participants
Patients newly diagnosed with severe OSAHS should perform muscle upper airway exercises using the AirwayGym app for 20 min a day for 90 days.
The intervention consists of myofunctional therapy (MT) using the AirwayGym app.: Intervention. Patient newly diagnosed with severe OSAHS should perform muscle upper airway exercises using the App AirwayGym 20 minutes a day during 90 days.
|
CONTROL GROUP
n=10 Participants
Patients newly diagnosed with severe OSAHS do no therapy for 90 days.
|
|---|---|---|
|
Epworth Sleepiness Scale
Epworth sleepiness scales (Baseline)
|
10.3 score on a scale
Interval 8.71 to 12.24
|
9.3 score on a scale
Interval 6.6 to 12.11
|
|
Epworth Sleepiness Scale
Epworth sleepiness scales (Three months)
|
5.3 score on a scale
Interval 3.45 to 7.2
|
9.6 score on a scale
Interval 6.8 to 12.3
|
SECONDARY outcome
Timeframe: Baseline and three monthsA scale (0- 21) obtained by a self-report questionnaire that assesses sleep quality over a 1-month time interval. The questionnaire consists of a combination of Likerttype and open-ended questions (later converted to scaled scores using provided guidelines). Respondents are asked to indicate how frequently they have experienced certain sleep difficulties over the past month and to rate their overall sleep quality. Scores for each question range from 0 to 3, with higher scores indicating more acute sleep disturbances.A global score of 5 or more indicates poor sleep quality and that the higher the score, the worse the quality of sleep. The questionnaire consists of 19 individual items, creating seven components that produce one global score, and takes 5-10 min to complete.
Outcome measures
| Measure |
INTERVENTION (AirwayGym) GROUP
n=18 Participants
Patients newly diagnosed with severe OSAHS should perform muscle upper airway exercises using the AirwayGym app for 20 min a day for 90 days.
The intervention consists of myofunctional therapy (MT) using the AirwayGym app.: Intervention. Patient newly diagnosed with severe OSAHS should perform muscle upper airway exercises using the App AirwayGym 20 minutes a day during 90 days.
|
CONTROL GROUP
n=10 Participants
Patients newly diagnosed with severe OSAHS do no therapy for 90 days.
|
|---|---|---|
|
Pittsburgh Sleep Quality Index
Pittsburgh sleep quality index (Baseline)
|
10.2 score on a scale
Interval 8.22 to 12.0
|
8.8 score on a scale
Interval 7.1 to 10.48
|
|
Pittsburgh Sleep Quality Index
Pittsburgh sleep quality index (Three Months)
|
10.3 score on a scale
Interval 8.71 to 12.2
|
9.78 score on a scale
Interval 7.2 to 12.1
|
Adverse Events
INTERVENTION (AirwayGym) GROUP
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
CONTROL GROUP
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
Francisco Jesus Gonzalez
Grupo Hospitalario Quironsalud
Phone: 0034645014593
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place