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Clinical Trials in France / NCT05911971
Starting soon Phase 3

Upper Airway Reeducation in Moderate Obstructive Sleep Apnea Syndrome

NCT05911971 · tracked via the Priya Life Science France tracker
Sponsor
Assistance Publique - Hôpitaux de Paris
Phase
Phase 3
Started
2023-07
Last updated
2023-06-22

Condition(s) studied

Moderate Obstructive Sleep Apnea Syndrome

Investigational drug(s) / intervention(s)

ExperimentalSham comparator

Experimental: specific reeducation (not detailed to maintain blinding of participants)

Sham comparator: sham reeducation (not detailed to maintain blinding of participants)

Study summary

The aim of this study is to evaluate the effectiveness of a specific reeducation performed by speech therapists in moderate obstructive sleep apnea syndrome, as an alternative to the continuous Positive Anyway Pressure (CPAP) and the mandibular advancement device.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Male or female, 18 years old minimum * Diagnosis of moderate OSAS: AHI ≥ 15 events/h and \< 30 events/h at PSG M0 * BMI \< 35 kg/m2 Exclusion Criteria: * MoCA \< 26 (Montreal Cognitive Assessment) * Craniofacial malformations * Regular use of hypnotic medications * Untreated hypothyroidism * Stroke history * Cardiac insufficiency * Severe uncontrolled coronary heart disease * Severe obstructive nasal disease * Patients with indication for CPAP in first intention * Pregnant or breastfeeding woman * Current participation in another interventional research in OSA * No affiliation to a social security system or legal beneficiary (except AME,Aide médicale d'état) * Absence of free, informed, written consent * Contraindications for TMS: intracranial metallic implant, pacemaker and/or recent or severe cardiac disease, epilepsy, vascular, traumatic, tumor, infectious or metabolic brain lesions, severe alcoholism * Protected adult under guardianship or curatorship

Primary outcome measure(s)

  • Change in apnea-hypopnea index (AHI) — between 0 and 3 months after randomization
    Apnea-hypopnea index (AHI) is the number of apnoeas or hypopnoeas per hour of sleep, measured by polysomnography during a minimum 6-hour night of inpatient sleep. Polysomnograms will be interpreted by a blinded somnologist.

Trial sites (1)

FacilityCityRegionStatus
Service des pathologies du sommeil, Pitié-Salpêtrière hospital Paris France

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05911971 on ClinicalTrials.gov ↗ ← All trials in France