NCT05911971

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at below P25 for phase_3

Timeline
5mo left

Started Jul 2023

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress88%
Jul 2023Oct 2026

First Submitted

Initial submission to the registry

June 12, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 22, 2023

Completed
9 days until next milestone

Study Start

First participant enrolled

July 1, 2023

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Expected
Last Updated

June 22, 2023

Status Verified

June 1, 2023

Enrollment Period

2.8 years

First QC Date

June 12, 2023

Last Update Submit

June 12, 2023

Conditions

Moderate Obstructive Sleep Apnea Syndrome

Outcome Measures

Primary Outcomes (1)

  • Change in apnea-hypopnea index (AHI)

    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.

    between 0 and 3 months after randomization

Secondary Outcomes (32)

  • 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 lingual strength

    between 0 and 3 months and between 0 and 6 months after randomization

  • Change of lingual endurance

    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

  • +27 more secondary outcomes

Study Arms (2)

Specific reeducation

EXPERIMENTAL

Specific reeducation

Other: Experimental

Sham comparator

SHAM COMPARATOR

Sham reeducation

Other: Sham comparator

Interventions

ExperimentalOTHER

specific reeducation (not detailed to maintain blinding of participants)

Specific reeducation
Sham comparatorOTHER

sham reeducation (not detailed to maintain blinding of participants)

Sham comparator

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service des pathologies du sommeil, Pitié-Salpêtrière hospital

Paris, 75013, France

Location

Study Officials

  • Diane PICARD-DUBOIS

    APHP

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Diane PICARD-DUBOIS

CONTACT

0142163157diane.picard@aphp.fr

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 12, 2023

First Posted

June 22, 2023

Study Start

July 1, 2023

Primary Completion

April 1, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

June 22, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will share

Data are available upon reasonable request The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Beginning 3 months and ending 3 years following article publication. Requests out of these time frame can also be submitted to the sponsor
Access Criteria
Researchers who provide a methodologically sound proposal.

Locations

FR(1)