Combination Therapy Associating CPAP and Mandibular Advancement Device in OSA (PPC-OAM)

May 20, 2022 updated by: University Hospital, Grenoble

Combination Therapy Associating CPAP and Mandibular Advancement Device ( MAD) in Obstructive Sleep Apnea (OSA) Low CPAP Compliers: A Randomized Controlled Trial

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

The aim of this study is to test the efficacy of a combination of Continuous Positive Airway Pressure (CPAP) treatment and a Mandibular Advancement Device (MAD) on the control of nocturnal Blood Pressure over a 3-month period in hypertensive obstructive sleep apnea being low CPAP compliers.

This is a prospective, randomized, open-label and multi-centric study. The investigators plan to include 105 hypertensive patients demonstrating low CPAP adherence (less than 4 hours per night). Patients will be randomly assigned to one of the following treatments: Education for improving CPAP adherence ('CPAP Only' group: patients will continue their CPAP treatment and be supported by regular coaching aimed at increasing their compliance to treatment); Mandibular Advancement Device ('MAD Only' group: patients will switch their treatment from CPAP to a MAD); a combination of CPAP and MAD ('CPAP + MAD' group: patients will be treated by both devices used simultaneously).

The duration of the study is 3 months. At the selection visit, patients will undergo a polysomnography/respiratory polygraphy followed by 24h- Ambulatory Blood Pressure Monitoring, PROMs (Quality of Life, Epworth Sleepiness Score) and a blood sample for biological parameters analysis. Patients will be then randomized to one of the three groups. Patients assigned to the 'CPAP only group' will be contacted by the homecare provider to arrange coaching sessions in order to improve their compliance to CPAP (phone calls and/or home visits). Patients assigned to the 'MAD Only group' will be proposed a Mandibular Advancement Device. Patients assigned to the 'CPAP+MAD group' will have both CPAP (with coaching) and a MAD.

After a 3-month treatment period, the same measurements (24h-Ambulatory Blood pressure, polysomnography/respiratory polygraphy, questionnaires, and blood sample analysis) will be repeated to compare efficacy of the 3 interventions. Tolerance (number of adverse events) and adherence to treatments will also be assessed.

The 'CPAP+MAD' group will be compared to the other two groups in order to evaluate the benefit of the combination therapy.

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France, 33073
        • Nouvelle Clinique Bel Air
      • Grenoble, France, 38000
        • University Hospital Grenoble
      • Montpellier, France
        • University Hospital Montpellier
      • Perpignan, France, 66000
        • Cabinet Medical

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Arterial Hypertension (Clinical Blood Pressure > 140/90 mmHg or patient under medication with nocturnal hypertension seen in the Ambulatory Blood Pressure Measurement)
  • Severe obstructive sleep apnea syndrome, treated by CPAP for more than 6 months and less than 5 years, with a compliance <4h/night
  • No contraindication to a treatment by Mandibular Advancement Device
  • Ability to understand study procedures and signed informed consent
  • Covered by French social security system or equivalent

Exclusion Criteria:

  • Central Obstructive Apnea (>20% Central Apneas/Hypopneas)
  • Pregnant or breastfeeding womens
  • Prisoners or persons who require protection by the law
  • Persons within the exclusion period of another study
  • Contraindication to a mandibular advancement device (oral-dental pathology, pathology of the temporo-mandibular articulation, poor periodontal status)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: CPAP only
Obstructive sleep apnea patients with CPAP treatment only
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.
Active Comparator: Mandibular Advancement Device only
Obstructive sleep apnea patients with Mandibular Advancement Device only
Device: Mandibular Advancement Device
Adjustable oral prosthesis which retains the lower mandible in an anterior position, thus limiting sleep apneas
Experimental: CPAP + Mandibular Advancement Device
Obstructive sleep apnea patients with combined CPAP and Mandibular Advancement Device
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nightime Mean Blood Pressure
Time Frame: 3 months
Difference in nighttime Mean Blood Pressure before and after treatment, measured by ambulatory blood pressure
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Other 24h ambulatory blood pressure measurements
Time Frame: 3 months
24h ambulatory blood pressure measurements (systolic, diastolic and mean, diurnal and nocturnal) before and after treatment
3 months
Blood Pressure Variability
Time Frame: 3 months
Blood Pressure variability before and after treatment, measured by ambulatory blood pressure measurements
3 months
Percent Dippers/dipping phenotypes
Time Frame: 3 months
Percentage of dipper patients (>10% drop in nocturnal Blood Pressure compared with daytime BP)
3 months
3-days home Blood Pressure measurements (systolic, diastolic)
Time Frame: 3 months
self-measurement of Systolic and Diastolic Blood Pressure, measured over 3 days, twice a day, before and after interventions
3 months
Epworth Score
Time Frame: 3 months
Score on the Epworth Sleepiness Questionnaire, before and after treatment. The ESS is a self-administered questionnaire with 8 questions. Patients are asked to rate, on a 4-point scale (0-3), their usual chances of dozing off or falling asleep while engaged in eight different activities. The ESS score (the sum of 8 sub-item scores( 0-3) can range from 0 to 24. The higher the ESS score the greater the likelihood that the person has daytime sleepiness.
3 months
Quality of Life score
Time Frame: 3 months
Score on the Quality Of Life Questionnaire SF12, before and after treatment. The SF-12 is a self-administered short survey with 12 questions assessing quality of life. The questions are combined, scored, and weighted to create two subscales (mental and social score and physical score) that provide glimpses into health-related quality of life. The lower the scores the more disability.
3 months
Serum concentration of Cholesterol
Time Frame: 3 months
Serum concentration of low-density lipoprotein cholesterol (LPL-C) and high-density lipoprotein cholesterol (HDL-C), before and after treatment.
3 months
Serum concentration of Triglycerides
Time Frame: 3 months
Serum concentration of Triglyceride, before and after treatment
3 months
Concentration of fasting Glucose
Time Frame: 3 months
Concentration of fasting glucose, before and after treatment
3 months
Amount of HbA1C
Time Frame: 3 months
Amount of HbA1c, before and after treatment
3 months
Incidence of adverse events related to the treatment
Time Frame: 3 months
Number of adverse events related to the treatment during the 3-month period
3 months
Compliance to treatment(s)
Time Frame: 3 months
Use of the device(s) defined by number of hour per night and number of night per week
3 months
Efficacy determined by comparison of Apnea-Hypopnea Index (AHI), number of central and obstructive apneas and hypopneas, before and after treatment
Time Frame: 3 months
AHI, central and obstructive apneas and hyponeas index, measured by polysomnography or polygraphy, before and after treatment
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Collaborators

ONIRIS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 18, 2019

Primary Completion (Actual)

March 3, 2020

Study Completion (Actual)

May 18, 2021

Study Registration Dates

First Submitted

June 18, 2019

First Submitted That Met QC Criteria

July 15, 2019

First Posted (Actual)

July 16, 2019

Study Record Updates

Last Update Posted (Actual)

May 26, 2022

Last Update Submitted That Met QC Criteria

May 20, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 38RC17.350

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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