Clinical trial NCT05911971: Upper Airway Reeducation in Moderate Obstructive Sleep Apnea Syndrome
Official title: Specific Upper Airway Reeducation in Moderate Obstructive Sleep Apnea Syndrome: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Moderate Obstructive Sleep Apnea Syndrome
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2023-06-22
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

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

Primary outcomes:
measure: Change in apnea-hypopnea index (AHI)
timeFrame: between 0 and 3 months after randomization
Secondary outcomes:
measure: Change of the Apnea-Hypopnea Index (AHI)
timeFrame: between 0 and 6 months after randomization
measure: Change of the MBLF(Bucco-Linguo-Facial Motor Function) score
timeFrame: between 0 and 3 months and between 0 and 6 months after randomization
measure: Change of the lingual strength
timeFrame: between 0 and 3 months and between 0 and 6 months after randomization
measure: Change of lingual endurance
timeFrame: between 0 and 3 months and between 0 and 6 months after randomization
measure: Change of the size of the genioglossus representation in cm² within the motor cortex
timeFrame: between 0 and 3 months after randomization
measure: Change of quality of life on the SF-36
timeFrame: between 0 and 3 months and between 0 and 6 months after randomization
measure: Change of sleep quality on the Pittsburgh Sleep Quality Index
timeFrame: between 0 and 3 months and between 0 and 6 months after randomization
measure: Change of daytime drowsiness on the Epworth Drowsiness Scale
timeFrame: between 0 and 3 months and between 0 and 6 months after randomization
measure: Presence of subjective symptoms , each taken independently
timeFrame: At 3 months and 6 months after randomization
measure: Change of the cervical circumference measurement (at the level of the cricoid)
timeFrame: between 0 and 3 months and between 0 and 6 months after randomization
measure: Change of the respiratory sensation sitting at rest
timeFrame: between 0 and 3 months and between 0 and 6 months after randomization
measure: Change of change in respiratory sensation between sitting and full decubitus
timeFrame: between 0 and 3 months and between 0 and 6 months after randomization
measure: Change of sleep latency
timeFrame: between 0 and 3 months and between 0 and 6 months after randomization
measure: Change of N3 latency
timeFrame: between 0 and 3 months and between 0 and 6 months after randomization
measure: Change of the paradoxical sleep latency
timeFrame: between 0 and 3 months and between 0 and 6 months after randomization
measure: change of sleep efficiency
timeFrame: between 0 and 3 months and between 0 and 6 months after randomization
measure: Change of the total sleep time (TST)
timeFrame: between 0 and 3 months and between 0 and 6 months after randomization
measure: Change of the length of the N1
timeFrame: between 0 and 3 months and between 0 and 6 months after randomization
measure: Change of the percentage (related to the TST) of the N1
timeFrame: between 0 and 3 months and between 0 and 6 months after randomization
measure: Change of the length of the N2
timeFrame: between 0 and 3 months and between 0 and 6 months after randomization
measure: Change of the percentage (related to the TST) of the N2
timeFrame: between 0 and 3 months and between 0 and 6 months after randomization
measure: Change of the length of the N3
timeFrame: between 0 and 3 months and between 0 and 6 months after randomization
measure: Change of the percentage (related to the TST) of the N3
timeFrame: between 0 and 3 months and between 0 and 6 months after randomization
measure: Change of the length of paradoxical sleep
timeFrame: between 0 and 3 months and between 0 and 6 months after randomization
measure: Change of the percentage (related to the TST) of paradoxical sleep
timeFrame: between 0 and 3 months and between 0 and 6 months after randomization
measure: Change of the length of intrasleep vigil
timeFrame: between 0 and 3 months and between 0 and 6 months after randomization
measure: Change of the percentage (related to the TST) of intrasleep vigil
timeFrame: between 0 and 3 months and between 0 and 6 months after randomization
measure: Change of the index of micro-awakenings
timeFrame: between 0 and 3 months and between 0 and 6 months after randomization
measure: Change of the index of micro-awakenings of respiratory origin
timeFrame: between 0 and 3 months and between 0 and 6 months after randomization
measure: Change of the number of periodic leg movements
timeFrame: between 0 and 3 months and between 0 and 6 months after randomization
measure: Change of number of sleep cycles
timeFrame: between 0 and 3 months and between 0 and 6 months after randomization
measure: Compliance with treatment
timeFrame: at 3 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Service des pathologies du sommeil, Pitié-Salpêtrière hospital
Study officials:
affiliation: APHP
name: Diane PICARD-DUBOIS
role: PRINCIPAL_INVESTIGATOR
References: