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Combination Therapy Associating CPAP and Mandibular Advancement Device in OSA

NCT04021810 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2022-05-26

No results posted yet for this study

Summary

The aim of this study is to evaluate the efficacy of a combination of Continuous Positive Airway Pressure (CPAP) and a Mandibular Advancement Device (MAD) on nocturnal Blood Pressure control in hypertensive patients in obstructive sleep apnea low CPAP compliers (less than 4 hours per night).

Hypertensive patients demonstrating low CPAP adherence will be selected during a screening visit; they will be then randomized to one of the three following arms: Education to CPAP ("CPAP only"), Treatment by a MAD ("MAD only") or a combination of both CPAP and MAD ("CPAP+MAD"). Mean systolic, diastolic, diurnal and nocturnal blood pressure will be assessed during 24-h Ambulatory Blood Pressure monitoring, before and after a 3-month treatment intervention. Biological laboratory parameters, patients reported outcomes (daytime sleepiness and Quality of Life), will also be evaluated before and after 3 months of treatment.

Conditions

Interventions

DEVICE

Continuous Positive Airway Pressure (CPAP) and patient education

Mask connected to a pump (CPAP machine) that forces air into the nasal passages at pressures high enough to overcome obstructions in the airways. Plus patient education.

DEVICE

Mandibular Advancement Device

Adjustable oral prosthesis which retains the lower mandible in an anterior position, thus limiting sleep apneas

Sponsors & Collaborators

  • ONIRIS

    collaborator INDUSTRY

  • University Hospital, Grenoble

    lead OTHER

Principal Investigators

  • Jean-Louis Pépin, Pr, PhD · University Hospital, Grenoble

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-18
Primary Completion
2020-03-03
Completion
2021-05-18

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04021810 on ClinicalTrials.gov