Impact of the Mandibular Advancement Device on Sleep Apnea During CPAP Withdrawal

NCT05939934 | Recruiting

• 1 other identifier: 49RC23_0078
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Obstructive sleep apnea hypopnea syndrome (OSAS) is a frequent disease with neuropsychological and cardiovascular (CV) consequences. Continuous positive pressure (CPAP), the main treatment for OSAHS, is effective on the majority of symptoms but restrictive, which can promote non-compliance. Treatment interruptions are often observed in connection with intercurrent events such as nasal obstructions or even when patients are on the move. However, randomized trials have shown that stopping treatment, even for a short time, leads to a recurrence of symptoms and significant CV disturbances (increase in blood pressure, endothelial dysfunction, cardiac repolarization disorders). It seems important to consider strategies that promote therapeutic continuity. The mandibular advancement device (MAD) is an interesting tool in this regard. MAD is as effective as CPAP on symptoms and CV data. The investigators want to assess its effectiveness as a complementary treatment during treatment discontinuation on the main consequences of OSAHS.

Conditions

Sleep Apnea, Obstructive; Endothelial Dysfunction

Outcome Measures

Primary Outcomes (1)

• Change in subjective sleepiness

  Sleepiness assessed using the Epworth Sleepiness Scale

  before and two weeks after CPAP withdrawal

Secondary Outcomes (11)

• Change in objective sleepiness

  before and two weeks after CPAP withdrawal

• Change in subjective sleep quality

  before and two weeks after CPAP withdrawal

• Change in executive function

  before and two weeks after CPAP withdrawal

• Change in 24 hour blood pressure

  before and two weeks after CPAP withdrawal

• Change in endothelial function

  before and two weeks after CPAP withdrawal

Study Arms (2)

control group

NO INTERVENTION

Patients will be ask not to use any OSAS treatment during the 2 weeks of the study (after the CPAP withdrawal)

mandibular advancement device

EXPERIMENTAL

Patients will be asked to use mandibular advancement device during the 2 weeks CPAP withdrawal

Device: Mandibular advancement device treatment

Interventions

Mandibular advancement device treatment DEVICE

a titratable thermoplastic mandibular advancement device will be proposed to patient in the experimental group during the 2 weeks of CPAP withdrawal.

mandibular advancement device

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient accepting MAD treatment
• Patient with an apnea-hypopnea index (AHI) greater than 30 events per hour on the initial recording
• Patient with excessive daytime sleepiness during initial treatment (ESE\>10)
• Patient treated for more than 12 months by CPAP with average compliance greater than 5 hours per night

You may not qualify if:

• Initial severe daytime sleepiness characterized
• OSAS with ≥ 5 central apneas per hour of sleep at baseline recording
• Previously diagnosed severe cardiac and/or respiratory pathology:
• Body mass index ≥ 35 kg/m2
• Known contraindication to OAM treatment

Sponsors & Collaborators

• University Hospital, Angers: lead

Study Sites (1)

Angers University Hospital

Angers, 49100, France

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• wojciech Trzepizur, MD PHD

  Angers University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

wojciech trzepizur, MD PHD

CONTACT

+3380575272; wotrezpizur@chu-angers.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: June 13, 2023
• First Posted: July 11, 2023
• Study Start: March 5, 2024
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: February 24, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)