Obstructive Sleep ApneaPACOAMNCT06568159
Patients with Coronary Artery Disease or At High Cardiovascular Risk: Measuring Compliance with Treatment for Obstructive Sleep Apnea Syndrome
An observational study of Obstructive Sleep Apnea and Coronary Disease, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Obstructive sleep apnea (OSA) is a sleep disorder characterised by partial or total obstruction of the oro-pharyngeal carrefour during sleep. It is found in between 4% and 25% of the general population and in 40 to 80% of patients with cardiovascular diseases. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea, Coronary Disease, Cardiovascular Diseases
- Type of treatment
- Pill or oral medicine
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 14 Feb 2025to 15 Feb 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects aged over 18, suffering from moderate to severe OSA and with CV pathology or at high risk of developing it.
Who may be able to join
- Target population: with coronary artery disease or at very high risk of coronary artery disease:
- Patients with coronary artery disease with or without co-morbidities (smoking, diabetes, hypertension, dyslipidaemia, renal insufficiency, overweight, emerging factors including anxiety-depression, shift workers, etc.).
- Hypertensive patients at high cardiovascular risk (target organ damage such as LVH or albuminuria)
- Diabetic patients at high cardiovascular risk
- Type of heart disease: ischaemic heart disease without clinically significant heart failure (NYHA II, III, IV) For the experimental group (MAD): patients with moderate or severe OSA with intolerance or refusal of CPAP and managed by MAD.
- For the control group (CPAP): patients with moderate or severe OSA treated with CPAP.
Who cannot join
- Patients with heart failure not stabilised according to the investigator (NYHA IV)
- Severe psychiatric disorders
- Pregnant or breast-feeding women
- Opposition to participation after a period of reflection
- Not affiliated to a social security scheme,
- Persons under court protection,
Show all 9Show fewer
- Persons under guardianship or curatorship
- Person taking part in another study with an exclusion period still in progress
- Inability to follow the patient during the study period.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU de MONTPELLIER
Montpellier, 34090
0467335046, c-francois@chu-montpellier.fr
About this study
Official title: Patients with Coronary Artery Disease or At High Cardiovascular Risk: Measuring Compliance with Treatment for Obstructive Sleep Apnea Syndrome (OAM or CPAP)
Obstructive sleep apnea (OSA) is a sleep disorder characterised by partial or total obstruction of the oro-pharyngeal carrefour during sleep. It is found in between 4% and 25% of the general population and in 40 to 80% of patients with cardiovascular diseases.
Continuous positive airway pressure (CPAP) is the standard treatment for OSA and its efficacy has already been demonstrated in this particular population. However, this treatment is not always accepted or sufficiently tolerated. The mandibular advancement device (MAD) is therefore an alternative treatment for OSA, validated by the French National Authority for Health and particularly relevant in this population because it is generally better tolerated. The aim of our study was to assess compliance, tolerance and usability of CPAP and MAD in patients with coronary artery disease and moderate (Apnea-Hypopnea Index AHI 15-30) to severe (AHI>30) OSA.
- Medical subject headings
- Sleep Apnea, Obstructive, Coronary Disease, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| MAD group | * An oral and dental check-up will be carried out on the day of inclusion, and a sleep diary will be provided. * Compliance will be assessed after 6 months' wear. * As part of the research, specific questionnaires will be completed with the patient during a telephone interview after 6 months: assessment of compliance and quality of life. | |
| CPAP group | * An oral and dental check-up will be carried out on the day of inclusion. * Compliance will be assessed after 6 months' wear. * As part of the research, specific questionnaires will be completed with the patient during a telephone interview after 6 months: assessment of compliance and quality of life. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compliance with MAD and CPAP at 6 months (wearing time).
MAD compliance at 6 months (wearing time): a sleep diary will be given to the patient at the inclusion visit.
CPAP compliance at 6 months: data transmitted by the CPAP device (sleep diary).
Measured: 6 months post-inclusion
Secondary outcomes (7)
Assessment of oral status
plaque index : values from 0 to 3. A high score is a worse outcome.
Measured: the day of inclusion
Assessment of oral status
mobility index : values from 1 to 4. A high score is a worse outcome.
Measured: the day of inclusion
Assessment of oral status
bleeding index : values from 0 to 1 (100%). A high score is a worse outcome.
Measured: the day of inclusion
Assessment of tolerance and satisfaction with the device used reported by the patient at 6 months (duration of wear)
survey : values from 0 to 3. A high score is a better outcome.
Measured: 6 months post-inclusion
Clinical parameters of OSA (objective)
ventilatory polygraphy or polysomnography
Measured: 6 months post-inclusion
Assessment of quality of life
Survey WHOQOL Bref. Values : very poor, poor, neither poor nor good, good, very good.
Measured: 6 months post-inclusion
Clinical parameters of OSA (subjective)
Survey. Values : light, moderate, significant
Measured: 6 months post-inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2024
- Study start14 Feb 2025
- Primary completion14 Feb 2026 (estimated)
- Study completion15 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06568159
- Sponsor's protocol ID
- RECHMPL23_0168
- Acronym
- PACOAM
- Status last verified
- Feb 2025
- First submitted
- 26 Jul 2024
- Last updated
- 18 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patients with Coronary Artery Disease or At High Cardiovascular Risk: Measuring Compliance with Treatment for Obstructive Sleep Apnea Syndrome (OAM or CPAP)
- ClinicalTrials.gov ID
- NCT06568159
- Acronym / sponsor ID
- PACOAM / RECHMPL23_0168
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 14 Feb 2025 (actual)
- Primary completion
- 14 Feb 2026 (estimated)
- Study completion
- 15 Feb 2026 (estimated)
- First posted
- 23 Aug 2024 (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.
Obstructive sleep apnea (OSA) is a sleep disorder characterised by partial or total obstruction of the oro-pharyngeal carrefour during sleep. It is found in between 4% and 25% of the general population and in 40 to 80% of patients with cardiovascular diseases.
Continuous positive airway pressure (CPAP) is the standard treatment for OSA and its efficacy has already been demonstrated in this particular population. However, this treatment is not always accepted or sufficiently tolerated. The mandibular advancement device (MAD) is therefore an alternative treatment for OSA, validated by the French National Authority for Health and particularly relevant in this population because it is generally better tolerated. The aim of our study was to assess compliance, tolerance and usability of CPAP and MAD in patients with coronary artery disease and moderate (Apnea-Hypopnea Index AHI 15-30) to severe (AHI>30) OSA.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MAD group | – | –* An oral and dental check-up will be carried out on the day of inclusion, and a sleep diary will be provided. * Compliance will be assessed after 6 months' wear. * As part of the research, specific questionnaires will be completed with the patient during a telephone interview after 6 months: assessment of compliance and quality of life. |
| CPAP group | – | –* An oral and dental check-up will be carried out on the day of inclusion. * Compliance will be assessed after 6 months' wear. * As part of the research, specific questionnaires will be completed with the patient during a telephone interview after 6 months: assessment of compliance and quality of life. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects aged over 18, suffering from moderate to severe OSA and with CV pathology or at high risk of developing it.
Key inclusion criteria (6 listed)
- Target population: with coronary artery disease or at very high risk of coronary artery disease:
- Patients with coronary artery disease with or without co-morbidities (smoking, diabetes, hypertension, dyslipidaemia, renal insufficiency, overweight, emerging factors including anxiety-depression, shift workers, etc.).
- Hypertensive patients at high cardiovascular risk (target organ damage such as LVH or albuminuria)
- Diabetic patients at high cardiovascular risk
- Type of heart disease: ischaemic heart disease without clinically significant heart failure (NYHA II, III, IV) For the experimental group (MAD): patients with moderate or severe OSA with intolerance or refusal of CPAP and managed by MAD.
Key exclusion criteria (9 listed)
- Patients with heart failure not stabilised according to the investigator (NYHA IV)
- Severe psychiatric disorders
- Pregnant or breast-feeding women
- Opposition to participation after a period of reflection
- Not affiliated to a social security scheme,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Compliance with MAD and CPAP at 6 months (wearing time).
Time frame: 6 months post-inclusion
MAD compliance at 6 months (wearing time): a sleep diary will be given to the patient at the inclusion visit. CPAP compliance at 6 months: data transmitted by the CPAP device (sleep diary).
7 secondary outcomes
Assessment of oral status
Time frame: the day of inclusion
Assessment of oral status
Time frame: the day of inclusion
Assessment of oral status
Time frame: the day of inclusion
Assessment of tolerance and satisfaction with the device used reported by the patient at 6 months (duration of wear)
Time frame: 6 months post-inclusion
Clinical parameters of OSA (objective)
Time frame: 6 months post-inclusion
Assessment of quality of life
Time frame: 6 months post-inclusion
Clinical parameters of OSA (subjective)
Time frame: 6 months post-inclusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2025.
- Individual participant dataSharing planned: No
Related trials for Obstructive Sleep Apnea
RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
Sleep-disordered Breathing, Chronic Opioid Use
Recruiting
Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 1/2
DRonabinol Treatment of OSA
Obstructive Sleep Apnea
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea and Coronary Disease, run by University Hospital, Montpellier at 1 site 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 9 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: looking for participants now, as of the sponsor's last update on 18 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cindy FRANCOIS (06 84 31 62 08, c-francois@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compliance with MAD and CPAP at 6 months (wearing time). (time frame: 6 months post-inclusion). 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 18 Feb 2025.