---
title: Combination Therapy Associating CPAP and Mandibular Advancement Device in OSA
nct_id: NCT04021810
overall_status: TERMINATED
phase: NA
sponsor: University Hospital, Grenoble
study_type: INTERVENTIONAL
primary_condition: Obstructive Sleep Apnea Syndrome
countries: France
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT04021810.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT04021810"
ct_last_update_post_date: 2022-05-26
last_seen_at: "2026-05-12T06:07:16.485Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Combination Therapy Associating CPAP and Mandibular Advancement Device in OSA

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

**NCT ID:** [NCT04021810](https://clinicaltrials.gov/study/NCT04021810)

## Key Facts

- **Status:** TERMINATED
- **Why Stopped:** Lack of faisability
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 5
- **Lead Sponsor:** University Hospital, Grenoble
- **Collaborators:** ONIRIS
- **Conditions:** Obstructive Sleep Apnea Syndrome, Hypertension
- **Start Date:** 2019-11-18
- **Completion Date:** 2021-05-18
- **CT.gov Last Update:** 2022-05-26

## Brief 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.

## 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.

## Eligibility

- **Minimum age:** 30 Years
- **Maximum age:** 75 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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)
```

## Arms

- **CPAP only** (ACTIVE_COMPARATOR) — Obstructive sleep apnea patients with CPAP treatment only
- **Mandibular Advancement Device only** (ACTIVE_COMPARATOR) — Obstructive sleep apnea patients with Mandibular Advancement Device only
- **CPAP + Mandibular Advancement Device** (EXPERIMENTAL) — Obstructive sleep apnea patients with combined CPAP and Mandibular Advancement Device

## Interventions

- **Continuous Positive Airway Pressure (CPAP) and patient education** (DEVICE) — 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.
- **Mandibular Advancement Device** (DEVICE) — Adjustable oral prosthesis which retains the lower mandible in an anterior position, thus limiting sleep apneas

## Primary Outcomes

- **Nightime Mean Blood Pressure** _(time frame: 3 months)_ — Difference in nighttime Mean Blood Pressure before and after treatment, measured by ambulatory blood pressure

## Secondary Outcomes

- **Other 24h ambulatory blood pressure measurements** _(time frame: 3 months)_
- **Blood Pressure Variability** _(time frame: 3 months)_
- **Percent Dippers/dipping phenotypes** _(time frame: 3 months)_
- **3-days home Blood Pressure measurements (systolic, diastolic)** _(time frame: 3 months)_
- **Epworth Score** _(time frame: 3 months)_
- **Quality of Life score** _(time frame: 3 months)_
- **Serum concentration of Cholesterol** _(time frame: 3 months)_
- **Serum concentration of Triglycerides** _(time frame: 3 months)_
- **Concentration of fasting Glucose** _(time frame: 3 months)_
- **Amount of HbA1C** _(time frame: 3 months)_
- **Incidence of adverse events related to the treatment** _(time frame: 3 months)_
- **Compliance to treatment(s)** _(time frame: 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)_

## Locations (4)

- Nouvelle Clinique Bel Air, Bordeaux, France
- University Hospital Grenoble, Grenoble, France
- University Hospital Montpellier, Montpellier, France
- Cabinet Médical, Perpignan, France

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.whyStopped` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.nouvelle clinique bel air|bordeaux||france` — added _(2026-05-12)_
- `locations.university hospital grenoble|grenoble||france` — added _(2026-05-12)_
- `locations.university hospital montpellier|montpellier||france` — added _(2026-05-12)_
- `locations.cabinet médical|perpignan||france` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT04021810.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT04021810*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*