Continuous Transcutaneous Electrical Stimulation in Sleep Apnoea
TESLA
Randomised, Double-blinded, Sham-controlled Cross-over Trial of Continuous Transcutaneous Electrical Stimulation of the Pharyngeal Dilator Muscles in Obstructive Sleep Apnoea
1 other identifier
interventional
44
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2013
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 2, 2012
CompletedFirst Posted
Study publicly available on registry
August 9, 2012
CompletedStudy Start
First participant enrolled
March 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedResults Posted
Study results publicly available
November 2, 2018
CompletedDecember 6, 2018
November 1, 2018
2.8 years
August 2, 2012
August 10, 2016
November 14, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
Apnoea-Hypopnoea Index (AHI)
1st sleep study compared to 2nd sleep study (randomised order of intervention/sham or sham/intervention)
Nadir Oxygenation
1st sleep study compared to 2nd sleep study (randomised order of intervention/sham or sham/intervention)
Patient Comfort
1st sleep study compared to 2nd sleep study (randomised order of intervention/sham or sham/intervention)
Device Acceptance
1st sleep study compared to 2nd sleep study (randomised order of intervention/sham or sham/intervention)
Sleepiness
1st sleep study compared to 2nd sleep study (randomised order of intervention/sham or sham/intervention)
Study Arms (2)
Transcutaneous electrical stimulation
ACTIVE COMPARATOROne night of transcutaneous electrical stimulation (electrical current titrated according to skin sensation)
Sham stimulation
SHAM COMPARATOROne night of sham stimulation (no electrical current)
Interventions
Transcutaneous electrical stimulation (one night of electrical current titrated according to skin sensation)
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Guy´s & St Thomas´ NHS Foundation Trust
London, United Kingdom
Related Publications (2)
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.10-2614. Epub 2011 Mar 31.
PMID: 21454399RESULTPengo MF, Xiao S, Ratneswaran C, Reed K, Shah N, Chen T, Douiri A, Hart N, Luo Y, Rafferty GF, Rossi GP, Williams A, Polkey MI, Moxham J, Steier J. Randomised sham-controlled trial of transcutaneous electrical stimulation in obstructive sleep apnoea. Thorax. 2016 Oct;71(10):923-31. doi: 10.1136/thoraxjnl-2016-208691. Epub 2016 Jul 19.
PMID: 27435610DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr Joerg Steier
- Organization
- 2Guy's and St Thomas' NHS Foundation Trust, Lane Fox Respiratory Unit/Sleep Disorders Centre, London, UK
Study Officials
- PRINCIPAL INVESTIGATOR
Joerg Steier, MD, PhD
Guy´s & St Thomas´ NHS Foundation Trust
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
August 2, 2012
First Posted
August 9, 2012
Study Start
March 1, 2013
Primary Completion
December 1, 2015
Study Completion
December 1, 2015
Last Updated
December 6, 2018
Results First Posted
November 2, 2018
Record last verified: 2018-11