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Completed

NCT Number: NCT04932486

Transcutaneous Electrical Stimulation in Obstructive Sleep Apnea

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.

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Key information

Conditions

Obstructive Sleep Apnea Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Respisom

Namur, 5000, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

transcutaneous electrical stimulation

Device

Transcutaneous electrical stimulation of the upper airway muscles

Primary outcomes

  1. Apnea-hypopnea index (AHI)

    Time frame: 6 weeks

    Change from baseline to 6 weeks in the apnea-hypopnea index (AHI)

Sponsors and collaborators

Lead sponsor

Sunrise

Industry

Registry information

Official study title

Randomised Controlled Trial of Transcutaneous Electrical Stimulation in Obstructive Sleep Apnea

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jun 21, 2021
Registry last updated
Apr 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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