Obstructive Sleep Apnoea Clinical Trial
— TESLAOfficial title:
Randomised, Double-blinded, Sham-controlled Cross-over Trial of Continuous Transcutaneous Electrical Stimulation of the Pharyngeal Dilator Muscles in Obstructive Sleep Apnoea
Verified date | November 2018 |
Source | Guy's and St Thomas' NHS Foundation Trust |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of this randomized, double-blinded, sham-controlled cross-over trial is to demonstrate the effectiveness of continuous transcutaneous electrical stimulation of the pharyngeal dilator muscles to reduce sleep-disordered breathing.
Status | Completed |
Enrollment | 44 |
Est. completion date | December 2015 |
Est. primary completion date | December 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: - males and females, age >18years and <75years, body-mass index (BMI) >18 and <40kg/m2, non-smokers, sleep apnoea with an ODI =15/h or sleep apnoea with an ODI =5/h plus an Epworth sleepiness score >10. Exclusion Criteria: - morbid obesity (BMI>40kg/m2) or cachexia (BMI<18kg/m2), obesity-hypoventilation syndrome (total sleep time with oxygen saturation (SpO2) less than 90% of more than 10% of the night), active smokers or smoking history of >20pack years, acute or critical illness, acute psychosis or chronic mental disorder affecting capacity, previous home-mechanical non-invasive ventilation and metal implants in the upper part of the body (this excludes dental implants). |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Guy´s & St Thomas´ NHS Foundation Trust | London |
Lead Sponsor | Collaborator |
---|---|
Guy's and St Thomas' NHS Foundation Trust |
United Kingdom,
Steier J, Seymour J, Rafferty GF, Jolley CJ, Solomon E, Luo Y, Man WD, Polkey MI, Moxham J. Continuous transcutaneous submental electrical stimulation in obstructive sleep apnea: a feasibility study. Chest. 2011 Oct;140(4):998-1007. doi: 10.1378/chest.10- — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 4% Oxygen Desaturation Index (ODI, 4%) | 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. |
1st sleep study compared to 2nd sleep study (randomised order of intervention/sham or sham/intervention) | |
Secondary | Apnoea-Hypopnoea Index (AHI) | 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. | 1st sleep study compared to 2nd sleep study (randomised order of intervention/sham or sham/intervention) | |
Secondary | Nadir Oxygenation | The nadir oxygenation (lowest SpO2, %) during the sleep study is measured while the patients are asleep. | 1st sleep study compared to 2nd sleep study (randomised order of intervention/sham or sham/intervention) | |
Secondary | Patient Comfort | 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. | 1st sleep study compared to 2nd sleep study (randomised order of intervention/sham or sham/intervention) | |
Secondary | Device Acceptance | Device acceptance during sleep study, as measured by a visual analogue scale (0-10points). Higher values in the scale range represent a better outcome. | 1st sleep study compared to 2nd sleep study (randomised order of intervention/sham or sham/intervention) | |
Secondary | Sleepiness | 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. | 1st sleep study compared to 2nd sleep study (randomised order of intervention/sham or sham/intervention) |
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