Back to resultsTranscutaneous Electrical Stimulation in Obstructive Sleep Apnea
Primary Purpose
Obstructive Sleep Apnea
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Transcutaneous electrical stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Obstructive Sleep Apnea
Eligibility Criteria
Inclusion criteria:
- Obstructive apnea-hypopnea index > 15 events/hour
- Patients who do not tolerate or do not accept positive airway pressure therapy
Main exclusion criteria:
- Body mass index < 18.5 or > 32 kg/m2
- Unable or incapable of providing informed written consent
- Unwilling or incapable of returning to all follow-up visits and sleep studies, including evaluation procedures and filling out questionnaires
- Significant co-morbidities making the patient unable or inappropriate to participate in the trial
Sites / Locations
- Respisom
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Transcutaneous electrical stimulation
Arm Description
Participants will be asked to use the stimulator for 6 weeks at home. The study objectives will be evaluated after 6 weeks post-activation of the device.
Outcomes
Primary Outcome Measures
Apnea-hypopnea index (AHI)
Change from baseline to 6 weeks in the apnea-hypopnea index (AHI)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04932486
Brief Title
Transcutaneous Electrical Stimulation in Obstructive Sleep Apnea
Official Title
Randomised Controlled Trial of Transcutaneous Electrical Stimulation in Obstructive Sleep Apnea
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
May 26, 2021 (Actual)
Primary Completion Date
April 13, 2023 (Actual)
Study Completion Date
April 13, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sunrise
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The aim of this study is to assess the efficacy of transcutaneous electrical stimulation of the upper airway muscles in patients with obstructive sleep apnea.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Transcutaneous electrical stimulation
Arm Type
Experimental
Arm Description
Participants will be asked to use the stimulator for 6 weeks at home. The study objectives will be evaluated after 6 weeks post-activation of the device.
Intervention Type
Device
Intervention Name(s)
Transcutaneous electrical stimulation
Intervention Description
Transcutaneous electrical stimulation of the upper airway muscles
Primary Outcome Measure Information:
Title
Apnea-hypopnea index (AHI)
Description
Change from baseline to 6 weeks in the apnea-hypopnea index (AHI)
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
Obstructive apnea-hypopnea index > 15 events/hour
Patients who do not tolerate or do not accept positive airway pressure therapy
Main exclusion criteria:
Body mass index < 18.5 or > 32 kg/m2
Unable or incapable of providing informed written consent
Unwilling or incapable of returning to all follow-up visits and sleep studies, including evaluation procedures and filling out questionnaires
Significant co-morbidities making the patient unable or inappropriate to participate in the trial
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Benoit Martinot
Organizational Affiliation
Respisom
Official's Role
Principal Investigator
Facility Information:
Facility Name
Respisom
City
Namur
ZIP/Postal Code
5000
Country
Belgium
12. IPD Sharing Statement
Learn more about this trial
Transcutaneous Electrical Stimulation in Obstructive Sleep Apnea
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