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NCT04932486 Clinical Trial

Transcutaneous Electrical Stimulation in Obstructive Sleep Apnea

Obstructive Sleep Apnea Clinical Trial

Official title:
Randomised Controlled Trial of Transcutaneous Electrical Stimulation in Obstructive Sleep Apnea

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04932486
Other study ID # B7072020000095
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 26, 2021
Est. completion date April 13, 2023

Study information
Verified date April 2023
Source Sunrise
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 42
Est. completion date April 13, 2023
Est. primary completion date April 13, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Transcutaneous electrical stimulation
Transcutaneous electrical stimulation of the upper airway muscles

Locations
Country Name City State
Belgium Respisom Namur

Sponsors (1)
Lead Sponsor Collaborator
Sunrise

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary Apnea-hypopnea index (AHI) Change from baseline to 6 weeks in the apnea-hypopnea index (AHI) 6 weeks
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