Active — Not RecruitingNot Applicable

Dual-sided Hypoglossal neRvE stimulAtion for the treatMent of Obstructive Sleep Apnea (DREAM)

United States115 participantsStarted 2020-10-14

Plain-language summary

A multicenter study to assess the safety and effectiveness of the Genio dual-sided hypoglossal nerve stimulation system for the treatment of obstructive sleep apnea in adults subjects.

Who can participate

Age range22 Years – 75 Years

SexALL

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Inclusion criteria

✓. Age from 22 to 75 years (inclusive). Participant cannot be under guardianship, under curatorship or under judicial protection.
✓. Body mass index (BMI) ≤ 32 kg/m2.
✓. Cricomental space positive (≥ 0 cm). The cricomental space is the distance between the neck and the bisection of a line from the chin to the cricoid membrane when the head is in a neutral position.
✓. Has either not tolerated, has failed or refused positive airway pressure (PAP) treatment
✓. Moderate to severe OSA (15≤AHI4≤65 where combined central and mixed AHI \< 25% of the total AHI) based on a screening PSG.
✓. Non-supine AHI \> 10 events on the screening PSG or participant has either not tolerated, has failed or refused positional therapy.
✓. Written informed consent obtained from the participant prior to performing any study specific procedure.
✓. Willing and capable to comply with all study requirements, including specific lifestyle considerations, performing all follow-up visits and sleep studies, evaluation procedures and questionnaires for the whole duration of the trial.

Exclusion criteria

✕. Inadequately treated sleep disorders other than OSA that would confound functional sleep assessment:
✕. Severe chronic insomnia
✕. Insufficient sleep syndrome (\<6 hours sleep per night)
✕. Narcolepsy
✕. Restless legs syndrome
✕. REM behavior disorder
✕. Others deemed sufficient disorders that would confound functional sleep assessment in the judgment of the investigator
✕. Night shift worker defined as individual working between the hours of 10:00 pm and 7:00 am at least 3 nights per working week.

What they're measuring

Change in Apnea Hypopnea Index (AHI4%)

Timeframe: 12 months

Change in Oxyhemoglobin Desaturation Index (ODI4%)

Timeframe: 12 months

Trial details

NCT IDNCT03868618

SponsorNyxoah S.A.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-02-20

View on ClinicalTrials.gov More Obstructive Sleep Apnea trials