Upper Airway Reeducation in Moderate Obstructive Sleep Apnea Syndrome (SAOSGENIO)

Assistance Publique - Hôpitaux de Paris

Status and phase: Not yet enrolling; Phase 3

Conditions: Moderate Obstructive Sleep Apnea Syndrome

Treatments: Other: Sham comparator; Other: Experimental

Study type: Interventional

Funder types: Other

Identifiers

NCT05911971

APHP210997

2021-A02688-33 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 54 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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54 participants in 2 patient groups

Specific reeducation

Experimental group

Description:

Specific reeducation

Treatment:

Other: Experimental

Sham comparator

Sham Comparator group

Description:

Sham reeducation

Treatment:

Other: Sham comparator