Trial Outcomes & Findings for Continuous Transcutaneous Electrical Stimulation in Sleep Apnoea (NCT NCT01661712)
NCT ID: NCT01661712
Last Updated: 2018-12-06
Results Overview
The primary outcome measure for this trial is the 4% oxygen desaturation index (ODI, 4%) per hour of sleep (h-1). The 4% ODI was chosen as primary outcome parameter over the AHI because an incomplete re-opening of the upper airway during an ongoing apnoeic effort caused by transcutaneous electrical stimulation (CTES) may result in a nominal increase of the AHI. We consider that the 4% ODI would be a more robust marker for the severity of sleep apnoea, low average oxygen levels indicating obesity-hypoventilation syndrome which will be an exclusion criterion. Although a specific cut off is not well defined a 4% ODI ≥5 represent mild OSA whilst a 4% ODI ≥15 represents moderate-severe OSA. Normal range is usually considered 0-5 events/hour.
COMPLETED
NA
44 participants
1st sleep study compared to 2nd sleep study (randomised order of intervention/sham or sham/intervention)
2018-12-06
Participant Flow
This is a randomised, sham-controlled crossover trial using transcutaneous electrical stimulation of the upper airway dilator muscles in patients with confirmed obstructive sleep apnea (OSA).
A total of 390 patients were assessed, 44 patients were screened. 8 patients were excluded as screening failures. 36 patients were randomised into the sequence 'Sham Stimulation, then True Stimulation' (n=18) or 'True Stimulation, then Sham Stimulation' (n-18). All 36 randomised subjects completed the trial, serving as their own control.
Participant milestones
| Measure |
Sham Stimulation, Then True Stimulation
The patient will 1st undergo a sleep study with Sham stimulation. An identical setup to the intervention will be used with the software indicating stimulation to keep staff blinded to the intervention.
Then patients will undergo a washout period (\>3nights) and return for a 2nd sleep study on true stimulation to complete the trial.
Transcutaneous electrical stimulation (SOSATS device, MORGAN Innovation\&Technology Ltd., Petersfield, UK):
The SOSATS unit is a first generation sleep apnoea research device which is programmed and controlled by an external personal computer (PC) or laptop via a visual interface. It stimulates the pharyngeal dilator muscles to reduce sleep apnoea.
|
Transcutaneous Electrical Stimulation, Then Sham Stimulation
The patient will undergo the 1st sleep study with continuous transcutaneous electrical stimulation.
Then patients will undergo a washout period (\>3nights) and return for a 2nd sleep study on sham stimulation to complete the trial.
Transcutaneous electrical stimulation (SOSATS device, MORGAN Innovation\&Technology ltd., Petersfield, UK):
The SOSATS unit is a first generation sleep apnoea research device which is programmed and controlled by an external PC or laptop via a visual interface. It stimulates the pharyngeal dilator muscles to reduce sleep apnoea.
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
18
|
|
Overall Study
Washout Period
|
18
|
18
|
|
Overall Study
COMPLETED
|
18
|
18
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Continuous Transcutaneous Electrical Stimulation in Sleep Apnoea
Baseline characteristics by cohort
| Measure |
Sham Stimulation First, Then Transcutaneous Electrical Stimula
n=18 Participants
The patient will undergo a sleep study and continuous transcutaneous electrical stimulation will be administered during the night. After 3 days of wash out the patient will undergo a sleep study with the sham intervention and no continuous transcutaneous electrical stimulation will be administered.
An identical setup to the intervention will be used with the software indicating stimulation to keep staff blinded to the intervention.
Transcutaneous electrical stimulation (SOSATS device, MORGAN Innovation\&Technology ltd., Petersfield, UK): The SOSATS unit is a first generation sleep apnoea research device which is programmed and controlled by an external PC or laptop via a visual interface.
It stimulates the pharyngeal dilator muscles in order to reduce sleep apnoea.
|
Transcutaneous Electrical Stimulation First, Then Sham Stimula
n=18 Participants
The patient will undergo a sleep study with Sham stimulation. After 3 days of wash out the patient will will undergo a sleep study and continuous transcutaneous electrical stimulation will be administered during the night An identical setup to the intervention will be used with the software indicating stimulation to keep staff blinded to the intervention.
Transcutaneous electrical stimulation (SOSATS device, MORGAN Innovation\&Technology ltd., Petersfield, UK): The SOSATS unit is a first generation sleep apnoea research device which is programmed and controlled by an external PC or laptop via a visual interface.
It stimulates the pharyngeal dilator muscles in order to reduce sleep apnoea.
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51.2 years
STANDARD_DEVIATION 11.9 • n=5 Participants
|
50.6 years
STANDARD_DEVIATION 11 • n=7 Participants
|
50.8 years
STANDARD_DEVIATION 11.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1st sleep study compared to 2nd sleep study (randomised order of intervention/sham or sham/intervention)The primary outcome measure for this trial is the 4% oxygen desaturation index (ODI, 4%) per hour of sleep (h-1). The 4% ODI was chosen as primary outcome parameter over the AHI because an incomplete re-opening of the upper airway during an ongoing apnoeic effort caused by transcutaneous electrical stimulation (CTES) may result in a nominal increase of the AHI. We consider that the 4% ODI would be a more robust marker for the severity of sleep apnoea, low average oxygen levels indicating obesity-hypoventilation syndrome which will be an exclusion criterion. Although a specific cut off is not well defined a 4% ODI ≥5 represent mild OSA whilst a 4% ODI ≥15 represents moderate-severe OSA. Normal range is usually considered 0-5 events/hour.
Outcome measures
| Measure |
Sham Stimulation
n=36 Participants
patients that underwent the Sham stimulation night study
|
Active Treatment
n=36 Participants
Patients that underwent the stimulation overnight sleep study
|
|---|---|---|
|
4% Oxygen Desaturation Index (ODI, 4%)
|
26.9 oxygen desaturation events/hour
Interval 17.5 to 39.5
|
19.5 oxygen desaturation events/hour
Interval 11.6 to 40.0
|
SECONDARY outcome
Timeframe: 1st sleep study compared to 2nd sleep study (randomised order of intervention/sham or sham/intervention)The Apnoea-Hypopnoea Index (AHI) is an index used to indicate the severity of sleep apnea. It is represented by the number of apnea and hypopnea events per hour of sleep. An apnea (pause in breathing) is defined by a temporary cessation of breathing that must last for at least 10 seconds and be associated with a decrease in blood oxygenation. A hypopnoea is a reduction of ventilation (shallow breathing) but not a complete cessation of breathing, lasting al least 10 seconds and associated with a decrease in blood oxygenation.
Outcome measures
| Measure |
Sham Stimulation
n=36 Participants
patients that underwent the Sham stimulation night study
|
Active Treatment
n=36 Participants
Patients that underwent the stimulation overnight sleep study
|
|---|---|---|
|
Apnoea-Hypopnoea Index (AHI)
|
33.8 events/hour
Interval 16.6 to 46.1
|
23.7 events/hour
Interval 11.4 to 47.6
|
SECONDARY outcome
Timeframe: 1st sleep study compared to 2nd sleep study (randomised order of intervention/sham or sham/intervention)The nadir oxygenation (lowest SpO2, %) during the sleep study is measured while the patients are asleep.
Outcome measures
| Measure |
Sham Stimulation
n=36 Participants
patients that underwent the Sham stimulation night study
|
Active Treatment
n=36 Participants
Patients that underwent the stimulation overnight sleep study
|
|---|---|---|
|
Nadir Oxygenation
|
81.0 % of haemoglobin that is oxygenated
Interval 74.0 to 84.0
|
80.5 % of haemoglobin that is oxygenated
Interval 74.5 to 86.0
|
SECONDARY outcome
Timeframe: 1st sleep study compared to 2nd sleep study (randomised order of intervention/sham or sham/intervention)Patient comfort during the sleep study, as measured by a visual analogue scale (0-10 points). Higher values in the scale range represent a better outcome.
Outcome measures
| Measure |
Sham Stimulation
n=36 Participants
patients that underwent the Sham stimulation night study
|
Active Treatment
n=36 Participants
Patients that underwent the stimulation overnight sleep study
|
|---|---|---|
|
Patient Comfort
|
6.4 units on a scale
Interval 2.4 to 8.0
|
5.6 units on a scale
Interval 2.9 to 7.1
|
SECONDARY outcome
Timeframe: 1st sleep study compared to 2nd sleep study (randomised order of intervention/sham or sham/intervention)Device acceptance during sleep study, as measured by a visual analogue scale (0-10points). Higher values in the scale range represent a better outcome.
Outcome measures
| Measure |
Sham Stimulation
n=36 Participants
patients that underwent the Sham stimulation night study
|
Active Treatment
n=36 Participants
Patients that underwent the stimulation overnight sleep study
|
|---|---|---|
|
Device Acceptance
|
9.9 units on a scale
Interval 9.5 to 10.0
|
9.9 units on a scale
Interval 9.7 to 10.0
|
SECONDARY outcome
Timeframe: 1st sleep study compared to 2nd sleep study (randomised order of intervention/sham or sham/intervention)Daytime sleepiness as an ad-hoc measurement, as measured by the Stanford Sleepiness Scale (0-7 points, x). Higher values in the scale range represent more severe sleepiness.
Outcome measures
| Measure |
Sham Stimulation
n=36 Participants
patients that underwent the Sham stimulation night study
|
Active Treatment
n=36 Participants
Patients that underwent the stimulation overnight sleep study
|
|---|---|---|
|
Sleepiness
|
3.0 units on a scale
Interval 2.0 to 3.0
|
3.0 units on a scale
Interval 2.0 to 3.5
|
Adverse Events
Sham Stimulation
Active Treatment
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Sham Stimulation
n=36 participants at risk
patients that underwent the Sham stimulation night study
|
Active Treatment
n=36 participants at risk
Patients that underwent the stimulation overnight sleep study
|
|---|---|---|
|
Psychiatric disorders
claustrophobia
|
2.8%
1/36 • Number of events 1
|
2.8%
1/36 • Number of events 1
|
Additional Information
Dr Joerg Steier
2Guy's and St Thomas' NHS Foundation Trust, Lane Fox Respiratory Unit/Sleep Disorders Centre, London, UK
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place