Transcutaneous Electrical Stimulation in Obstructive Sleep Apnea

Sunrise

Status: Completed

Conditions: Obstructive Sleep Apnea

Treatments: Device: Transcutaneous electrical stimulation

Study type: Interventional

Funder types: Industry

Identifiers

NCT04932486

B7072020000095

Details and patient eligibility

About

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.

Enrollment: 42 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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42 participants in 1 patient group

Transcutaneous electrical stimulation

Experimental group

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.

Treatment:

Device: Transcutaneous electrical stimulation