Upper Airway Reeducation in Moderate Obstructive Sleep Apnea Syndrome
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Experimental, Sham comparator.
- Who it may be relevant to
- Registry conditions: Moderate Obstructive Sleep Apnea Syndrome. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Specific Upper Airway Reeducation in Moderate Obstructive Sleep Apnea Syndrome: a Randomized Controlled Trial
Overview
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.
Detailed 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.
Interventions
- Other Experimental
specific reeducation (not detailed to maintain blinding of participants) - Other Sham comparator
sham reeducation (not detailed to maintain blinding of participants)
Primary outcome measures
- Change in apnea-hypopnea index (AHI) [Time frame: between 0 and 3 months after randomization]
Secondary outcome measures (12)
- Change of the Apnea-Hypopnea Index (AHI) [Time frame: between 0 and 6 months after randomization]
- Change of the MBLF(Bucco-Linguo-Facial Motor Function) score [Time frame: between 0 and 3 months and between 0 and 6 months after randomization]
- Change of the lingual strength [Time frame: between 0 and 3 months and between 0 and 6 months after randomization]
- Change of lingual endurance [Time frame: between 0 and 3 months and between 0 and 6 months after randomization]
- Change of the size of the genioglossus representation in cm² within the motor cortex [Time frame: between 0 and 3 months after randomization]
- Change of quality of life on the SF-36 [Time frame: between 0 and 3 months and between 0 and 6 months after randomization]
- Change of sleep quality on the Pittsburgh Sleep Quality Index [Time frame: between 0 and 3 months and between 0 and 6 months after randomization]
- Change of daytime drowsiness on the Epworth Drowsiness Scale [Time frame: between 0 and 3 months and between 0 and 6 months after randomization]
- Presence of subjective symptoms , each taken independently [Time frame: At 3 months and 6 months after randomization]
- Change of the cervical circumference measurement (at the level of the cricoid) [Time frame: between 0 and 3 months and between 0 and 6 months after randomization]
- Change of the respiratory sensation sitting at rest [Time frame: between 0 and 3 months and between 0 and 6 months after randomization]
- Change of change in respiratory sensation between sitting and full decubitus [Time frame: between 0 and 3 months and between 0 and 6 months after randomization]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
France · 1 center
- Service des pathologies du sommeil, Pitié-Salpêtrière hospital — Paris
Identifiers
NCT: NCT05911971 · APHP210997 · 2021-A02688-33