RecruitingNot ApplicableNCT05939934

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

Impact of the Mandibular Advancement Device on Sleep Apnea Syndrome During Discontinuation of Treatment With Continuous Positive Airway Pressure: Randomized Controlled Trial


Sponsor

University Hospital, Angers

Enrollment

40 participants

Start Date

Mar 5, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria4

  • Patient accepting MAD treatment
  • Patient with an apnea-hypopnea index (AHI) greater than 15 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

Exclusion Criteria5

  • 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

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Interventions

DEVICEMandibular advancement device treatment

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


Locations(1)

Angers University Hospital

Angers, France

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NCT05939934


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