Upper Airway Reeducation in Moderate Obstructive Sleep Apnea Syndrome

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

NOT_YET_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-31

Study Completion Date

2026-10-31

Brief Summary

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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.

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Detailed Description

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Patients will be recruited in the sleep pathology department, following a sleep consultation and/or a polysomnography. They will be randomized between 2 reeducation groups (specific reeducation or sham reeducation) and will have to perform their respective exercises during 3 months. Only one of the 2 reeducations is expected to be effective. To limit performance and measure bias, patients will not be aware of the content of the reeducation in the other group (participants partially blinded of study hypothesis) and therefore these are not described in detail here. The initial clinical assessment will be repeated at 3 and 6 months, by assessors blinded to the reeducation arm, in order to evaluate the short and medium term effectiveness on the the Apnea-Hypopnea Index (AHI) and other outcomes.

Conditions

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Moderate Obstructive Sleep Apnea Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Specific reeducation

Group Type EXPERIMENTAL

Experimental

Intervention Type OTHER

specific reeducation (not detailed to maintain blinding of participants)

Sham comparator

Sham reeducation

Group Type SHAM_COMPARATOR

Sham comparator

Intervention Type OTHER

sham reeducation (not detailed to maintain blinding of participants)

Interventions

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Experimental

specific reeducation (not detailed to maintain blinding of participants)

Intervention Type OTHER

Sham comparator

sham reeducation (not detailed to maintain blinding of participants)

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No