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临床试验/NCT05911971
NCT05911971尚未招募3 期

Specific Upper Airway Reeducation in Moderate Obstructive Sleep Apnea Syndrome: a Randomized Controlled Trial

Assistance Publique - Hôpitaux de Paris2 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2023年7月最近更新:
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适应症

试验速览

阶段
3 期
状态
尚未招募
入组人数
54
试验地点
2
主要终点
Change in apnea-hypopnea index (AHI)
研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —（Adult, Older Adult）
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •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

结局指标

主要结局

Change in apnea-hypopnea index (AHI)

时间窗: 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.

次要结局

  • Change of lingual endurance(between 0 and 3 months and between 0 and 6 months after randomization)
  • Change of the total sleep time (TST)(between 0 and 3 months and between 0 and 6 months after randomization)
  • Change of the length of the N1(between 0 and 3 months and between 0 and 6 months after randomization)
  • Change of the percentage (related to the TST) of the N3(between 0 and 3 months and between 0 and 6 months after randomization)
  • Presence of subjective symptoms , each taken independently(At 3 months and 6 months after randomization)
  • Change of the percentage (related to the TST) of paradoxical sleep(between 0 and 3 months and between 0 and 6 months after randomization)
  • Change of the lingual strength(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(between 0 and 3 months after randomization)
  • Change of N3 latency(between 0 and 3 months and between 0 and 6 months after randomization)
  • Change of the paradoxical sleep latency(between 0 and 3 months and between 0 and 6 months after randomization)
  • change of sleep efficiency(between 0 and 3 months and between 0 and 6 months after randomization)
  • Change of the index of micro-awakenings of respiratory origin(between 0 and 3 months and between 0 and 6 months after randomization)
  • Change of the Apnea-Hypopnea Index (AHI)(between 0 and 6 months after randomization)
  • Change of the MBLF(Bucco-Linguo-Facial Motor Function) score(between 0 and 3 months and between 0 and 6 months after randomization)
  • Change of the cervical circumference measurement (at the level of the cricoid)(between 0 and 3 months and between 0 and 6 months after randomization)
  • Change of the respiratory sensation sitting at rest(between 0 and 3 months and between 0 and 6 months after randomization)
  • Change of sleep latency(between 0 and 3 months and between 0 and 6 months after randomization)
  • Change of the percentage (related to the TST) of the N1(between 0 and 3 months and between 0 and 6 months after randomization)
  • Change of the length of paradoxical sleep(between 0 and 3 months and between 0 and 6 months after randomization)
  • Change of the percentage (related to the TST) of intrasleep vigil(between 0 and 3 months and between 0 and 6 months after randomization)
  • Change of quality of life on the SF-36(between 0 and 3 months and between 0 and 6 months after randomization)
  • Change of sleep quality on the Pittsburgh Sleep Quality Index(between 0 and 3 months and between 0 and 6 months after randomization)
  • Change of daytime drowsiness on the Epworth Drowsiness Scale(between 0 and 3 months and between 0 and 6 months after randomization)
  • Change of the percentage (related to the TST) of the N2(between 0 and 3 months and between 0 and 6 months after randomization)
  • Change of the length of the N3(between 0 and 3 months and between 0 and 6 months after randomization)
  • Change of the length of intrasleep vigil(between 0 and 3 months and between 0 and 6 months after randomization)
  • Change of the number of periodic leg movements(between 0 and 3 months and between 0 and 6 months after randomization)
  • Change of change in respiratory sensation between sitting and full decubitus(between 0 and 3 months and between 0 and 6 months after randomization)
  • Change of the length of the N2(between 0 and 3 months and between 0 and 6 months after randomization)
  • Change of the index of micro-awakenings(between 0 and 3 months and between 0 and 6 months after randomization)
  • Change of number of sleep cycles(between 0 and 3 months and between 0 and 6 months after randomization)
  • Compliance with treatment(at 3 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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