OSAREMAPNCT05435794
Long-term Benefits of CPAP or MAD Treatment on the Sleep of OSAS Patients
An observational study of OSA, run by ResMed at 9 sites in France.
Trial summary
The REMAP study aims to follow a cohort of 400 patients in around ten sleep centers in France and to collect clinical routine data. The objectives of this study are to investigate the effects of one-year management of OSA by CPAP or MAD on sleep architecture defined by objective macro and micro sleep architecture… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- OSA
- What is being tested?
- CPAP and MAD
- Type of treatment
- Medical device
- How many people
- 400 participants
- Where
- 9 sitesFrance
- Study dates
- 15 Jul 2022to 15 Oct 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients will be recruited based on scheduled appointments at the various centers that participate in the SunSAS clinical trial and are diagnosed and managed for their OSA in accordance with standard practice.
Who may be able to join
- Patient already included in the SunSAS study (No. ID/RCB: 2021-A01827-34) or Patient who has undergone polygraphy or polysomnography eligible for treatment with CPAP or MAD in the context of OSA.
- Patient with a sleep test performed with the Sunrise device
- Men or Women from 18 to 80 years old
- Patient with OSAS eligible for CPAP or MAD therapy
- Affiliated patient or beneficiary of a social security scheme
- Signed informed consent
Who cannot join
- Patient previously treated for OSAS by CPAP or MAD during the last five years
- Patient with COPD or other respiratory diseases.
- Patient with contraindications to PPC or MAD therapy
- Patient with unstable heart disease or New York Heart Association class III or IV heart failure
- Patient unable to complete the study
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
France9 sites, 9 recruiting
- Recruiting
CHU Angers
Angers, 49933
Frédéric GAGNADOUX, Prof.
- Recruiting
Centre Hospitalier Universitaire Grenoble Alpes
Grenoble, 38043
Jean Louis PEPIN, Pr
- Recruiting
CHU Lyon - Hôpital de la Croix-Rousse
Lyon, 69004
Laure Peter-Derex, Dr
- Recruiting
Hopital Europeen Marseille
Marseille, 13003
Hervé PEGLIASCO, Pr
- Recruiting
APHP - Pitié-Salpêtrière University Hospital
Paris, 75013
Maxime PATOUT, Dr
- Not yet recruiting
AP-HP Bichat
Paris, 75018
Marie-Pia D'Ortho, Pr
- Recruiting
CHU Reims
Reims, 51092
Claire Launois, Dr
- Recruiting
Polyclinique St Laurent
Rennes
Arnaud PRIGENT, Dr
- Recruiting
Centre du Sommeil
Saint-Martin-d'Hères, 38400
Renaud Tamisier, Pr
About this study
Official title: Long-term Benefits of Continuous Positive Pressure Therapy or Mandibular Advancement Devise on the Sleep of Patients With Obstructive Sleep Apnea
The REMAP study aims to follow a cohort of 400 patients in around ten sleep centers in France and to collect clinical routine data. The objectives of this study are to investigate the effects of one-year management of OSA by CPAP or MAD on sleep architecture defined by objective macro and micro sleep architecture parameters using a sleep test device. sleep connected at home, to assess the quality of sleep and the quality of life reported by patients. The study will also allow us to define predictive factors for improving sleep quality during OSA treatment.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPAPDevice
Fixed-pressure CPAP device for the treatment of sleep apnea with optional humidification and heated circuit. This device is a Class II device. It has a remote monitoring function allowing service providers to track the use of the device.
MADDevice
mandibular device orthosis made to measure from the dental impressions of patients, made by the specialist in the masticatory apparatus for the treatment of sleep apnea.
| Study group | Role | What they receive |
|---|---|---|
| Patient treated with CPAP | Not described Receives: Device: CPAP | |
| Patient treated with MAD | Not described Receives: Device: MAD |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the evolution of deep slow-wave sleep at one year in OSA patients according to the treatment initiated by continuous positive pressure or mandibular advancement device (MAD).
Objective evolution of deep slow-wave sleep time. Changes collected with a home-connected sleep testing device by comparing data from the initial visit (diagnosis) with data collected at 12 months (± 2 weeks) in a patient treated with CPAP or MAD.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2022
- Study start15 Jul 2022
- Primary completion15 Oct 2022
- Study completion15 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OSAStudies of the same condition, open and under way.
- More trials run by ResMedThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ResMed
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05435794
- Sponsor's protocol ID
- 2022-A00629-34
- Acronym
- REMAP
- Status last verified
- May 2024
- First submitted
- 14 Jun 2022
- Last updated
- 21 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Benefits of Continuous Positive Pressure Therapy or Mandibular Advancement Devise on the Sleep of Patients With Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT05435794
- Acronym / sponsor ID
- REMAP / 2022-A00629-34
- Conditions
- OSA
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- ResMedIndustry (pharma, biotech, devices)
- Study start
- 15 Jul 2022 (actual)
- Primary completion
- 15 Oct 2022 (actual)
- Study completion
- 15 Oct 2026 (estimated)
- First posted
- 28 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The REMAP study aims to follow a cohort of 400 patients in around ten sleep centers in France and to collect clinical routine data. The objectives of this study are to investigate the effects of one-year management of OSA by CPAP or MAD on sleep architecture defined by objective macro and micro sleep architecture parameters using a sleep test device. sleep connected at home, to assess the quality of sleep and the quality of life reported by patients. The study will also allow us to define predictive factors for improving sleep quality during OSA treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient treated with CPAP | – | Device: CPAP |
| Patient treated with MAD | – | Device: MAD |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be recruited based on scheduled appointments at the various centers that participate in the SunSAS clinical trial and are diagnosed and managed for their OSA in accordance with standard practice.
Key inclusion criteria (6 listed)
- Patient already included in the SunSAS study (No. ID/RCB: 2021-A01827-34) or Patient who has undergone polygraphy or polysomnography eligible for treatment with CPAP or MAD in the context of OSA.
- Patient with a sleep test performed with the Sunrise device
- Men or Women from 18 to 80 years old
- Patient with OSAS eligible for CPAP or MAD therapy
- Affiliated patient or beneficiary of a social security scheme
Key exclusion criteria (5 listed)
- Patient previously treated for OSAS by CPAP or MAD during the last five years
- Patient with COPD or other respiratory diseases.
- Patient with contraindications to PPC or MAD therapy
- Patient with unstable heart disease or New York Heart Association class III or IV heart failure
- Patient unable to complete the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CPAPFixed-pressure CPAP device for the treatment of sleep apnea with optional humidification and heated circuit. This device is a Class II device. It has a remote monitoring function allowing service providers to track the use of the device. | Device | Patient treated with CPAP |
| MADmandibular device orthosis made to measure from the dental impressions of patients, made by the specialist in the masticatory apparatus for the treatment of sleep apnea. | Device | Patient treated with MAD |
Primary outcome
To determine the evolution of deep slow-wave sleep at one year in OSA patients according to the treatment initiated by continuous positive pressure or mandibular advancement device (MAD).
Time frame: 12 months
Objective evolution of deep slow-wave sleep time. Changes collected with a home-connected sleep testing device by comparing data from the initial visit (diagnosis) with data collected at 12 months (± 2 weeks) in a patient treated with CPAP or MAD.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of OSA, run by ResMed at 9 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elodie Aversenq (+33426100200, elodie.aversenq@resmed.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the evolution of deep slow-wave sleep at one year in OSA patients according to the treatment initiated by continuous positive pressure or mandibular advancement device (MAD). (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2024.