N/A
N=36
Continuous Transcutaneous Electrical Stimulation in Sleep Apnoea
Obstructive Sleep Apnoea
Bottom Line
View on ClinicalTrials.gov: NCT01661712 ↗Enrolled (actual)
36
Serious AEs
0.0%
Results posted
Nov 2018
Primary outcome: Primary: 4% Oxygen Desaturation Index (ODI, 4%) — 26.9; 19.5 oxygen desaturation events/hour
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Transcutaneous electrical stimulation (Device); Sham stimulation (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Primary completion
- Dec 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 4% Oxygen Desaturation Index (ODI, 4%) |
26.9; 19.5 | — |
| SECONDARY Apnoea-Hypopnoea Index (AHI) |
33.8; 23.7 | — |
| SECONDARY Nadir Oxygenation |
81.0; 80.5 | — |
| SECONDARY Patient Comfort |
6.4; 5.6 | — |
| SECONDARY Device Acceptance |
9.9; 9.9 | — |
| SECONDARY Sleepiness |
3.0; 3.0 | — |
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.
Eligibility Criteria
Inclusion Criteria
- males and females, age >18years and 18 and 10.
Exclusion Criteria
- morbid obesity (BMI>40kg/m2) or cachexia (BMI 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).
Data sourced from ClinicalTrials.gov (NCT01661712). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.