Transcutaneous Electrical Stimulation in Obstructive Sleep Apnea

NCT ID: NCT04932486

Last Updated: 2023-04-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-26

Study Completion Date

2023-04-13

Brief Summary

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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.

Detailed Description

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Conditions

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Obstructive Sleep Apnea

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Transcutaneous electrical stimulation

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.

Group Type EXPERIMENTAL

Transcutaneous electrical stimulation

Intervention Type DEVICE

Transcutaneous electrical stimulation of the upper airway muscles

Interventions

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Transcutaneous electrical stimulation

Transcutaneous electrical stimulation of the upper airway muscles

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Obstructive apnea-hypopnea index \> 15 events/hour
* Patients who do not tolerate or do not accept positive airway pressure therapy

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sunrise

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jean-Benoit Martinot

Role: PRINCIPAL_INVESTIGATOR

Respisom

Locations

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Respisom

Namur, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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B7072020000095

Identifier Type: -

Identifier Source: org_study_id

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