Sleep Apnea Syndrome, ObstructiveSUNCPAPNCT07530302
Treatment Failure of Continuous Positive Airway Pressure (CPAP) in Patients With Obstructive Sleep Apnea Syndrome (OSA): A Trial Comparing Polysomnography and the Sunrise Device to Drive Treatment-Adjustment Decisions.
A study testing Sunrise in people with Sleep Apnea Syndrome, Obstructive, run by University Hospital, Grenoble at 1 site in France.
Trial summary
The goal of this clinical trial is to determine whether treatment-adjustment decisions based on one night of home monitoring with the Sunrise device are comparable to decisions based on one night of in-laboratory polysomnography (PSG) in adults with obstructive sleep apnea (OSA) who remain insufficiently controlled… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Sleep Apnea Syndrome, Obstructive
- What is being tested?
- Sunrise
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteFrance
- Study dates
- 10 Jun 2026to Sep 2029
- Phase
- Interventional
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 to 85 years
- Patients treated with Resmed CPAP
- Residual apnea-hypopnea index under CPAP (rAHI(CPAP) > 10 events/hour)
- Access to a smartphone and home internet connection, and ability to use a mobile application
- Signed informed consent
- Affiliated with, or beneficiary of, a national health insurance program
Who cannot join
- Severe chronic obstructive or restrictive pulmonary disease, with or without supplemental oxygen
- Unstable cardiovascular disease or severe heart failure requiring hospitalization within the past 3 months, or meeting New York Heart Association (NYHA) class III or IV criteria
- Conditions affecting mandibular condyle rotation or temporomandibular joint function
- Refusal to shave excessive facial hair when required for proper placement of the Sunrise device
- Participation in another interventional clinical study or currently within an exclusion period of another study
- Individuals who, in the investigator's judgment, are unlikely to comply with study procedures or requirements
Show all 9Show fewer
- Individuals who cannot be contacted in case of emergency
- Persons protected under French Public Health Code articles L1121-5, L1121-6, and L1121-8 (including pregnant or breastfeeding women, persons deprived of liberty, individuals under psychiatric care under articles L.3212-1 or L.3213-1, individuals admitted to healthcare or social institutions for reasons other than research, and persons under legal protection or unable to provide informed consent)
- Staff members with a hierarchical relationship to the principal investigator
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 Grenoble Alpes
Grenoble, 38043
Marie Joyeux-Faure, MD, 33(0)476767166, MJoyeuxfaure@chu-grenoble.fr
About this study
Official title: Treatment Failure of Continuous Positive Airway Pressure (CPAP) in Patients With Obstructive Sleep Apnea Syndrome (OSA): A Randomized Controlled Trial Comparing Polysomnography and the Sunrise Device to Drive Treatment-Adjustment Decisions.
The goal of this clinical trial is to determine whether treatment-adjustment decisions based on one night of home monitoring with the Sunrise device are comparable to decisions based on one night of in-laboratory polysomnography (PSG) in adults with obstructive sleep apnea (OSA) who remain insufficiently controlled with continuous positive airway pressure (CPAP) therapy.
The main questions it aims to answer are:
Read more
- Do Sunrise-based assessments lead to similar therapeutic decisions as PSG-based assessments?
- Are residual apnea-hypopnea indices measured by Sunrise comparable to those measured by PSG?
Participants will complete both assessment sequences in a randomized cross-over design. They will:
- Use the Sunrise device for several nights with and without CPAP.
- Undergo one night of PSG with and without CPAP.
- Have their CPAP therapy reviewed based on the results of each assessment method.
Read the detailed description
Obstructive sleep apnea (OSA) affects nearly one billion adults worldwide and is associated with recurrent upper-airway obstruction during sleep, leading to intermittent hypoxemia and multiple cardiometabolic and neurocognitive comorbidities. Continuous positive airway pressure (CPAP) is the standard treatment and is widely prescribed, with more than 1.8 million users in France. Despite its proven efficacy, large-scale analyses show that over 10% of treated patients continue to exhibit elevated residual apnea-hypopnea indices (AHI), a situation associated with reduced adherence and premature discontinuation of therapy.
Evaluation of CPAP effectiveness typically relies on in-laboratory polysomnography (PSG), which remains the reference method for characterizing residual respiratory events and sleep architecture. However, the need for PSG generates substantial healthcare costs, long waiting times, and unequal access to diagnostic resources.
The Sunrise device is a CE-marked medical device that records mandibular movements during sleep and uses artificial intelligence to characterize respiratory events and sleep parameters. Multiple validation studies have demonstrated strong agreement between Sunrise-derived metrics and PSG.
This randomized cross-over trial investigates whether Sunrise can be used to guide therapeutic decisions in patients with insufficiently controlled OSA under CPAP therapy, defined by a residual AHI greater than 10 events per hour. Participants are randomized to one of two sequences:
- Sunrise assessments first, consisting of several nights with and without CPAP, followed by one night of PSG with and without CPAP; or
- PSG assessments first, followed by the Sunrise sequence.
This design allows each participant to serve as their own control and enables direct comparison of treatment-adjustment decisions derived from Sunrise versus PSG. The study aims to determine whether a home-based, low-burden assessment could replace or reduce the need for in-laboratory evaluations, thereby improving access to care, reducing costs, and facilitating personalized CPAP management.
- Conditions
- Sleep Apnea Syndrome, Obstructive
- Being tested
- Sunrise
- Keywords
- Obstructive sleep apnea, Randomized, Cross-over, CPAP
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SunriseDevice
The Sunrise device is a single-use, mandibular movement-based sleep monitoring sensor designed to assess sleep architecture and respiratory events at home. In this study, Sunrise is evaluated as an alternative to in-laboratory polysomnography (PSG), which is considered the current gold-standard reference for sleep assessment.
| Study group | Role | What they receive |
|---|---|---|
| PSG-SUN | Other | Participants will first undergo an overnight, in-laboratory polysomnography (PSG) in the sleep center. After this in-lab recording period, they will complete an at-home sleep assessment using the Sunrise device over the predefined home recording period. Receives: Device: Sunrise |
| SUN-PSG | Other | Participants will first complete an at-home sleep assessment using the Sunrise device over the predefined home recording period. After this home recording period, they will undergo an overnight, in-laboratory polysomnography (PSG) in the sleep center. Receives: Device: Sunrise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cohen's Kappa for Agreement Between Therapeutic Adjustment Decisions Based on Sunrise and Polysomnography (PSG)
Agreement between therapeutic adjustment decisions derived from Sunrise home recordings and in-lab polysomnography (PSG), quantified using Cohen's kappa coefficient. Two independent experts will provide decisions for each modality; disagreements will be resolved by consensus.
The therapeutic decision is a three-category variable: No change in CPAP treatment, adjustment of CPAP pressure or change of mask, switch to servo-ventilation if residual events are predominantly central.
Measured: Within 1 night for each modality (Sunrise home recording and in-lab PSG).
Secondary outcomes (3)
Cohen's Kappa for Agreement Between Therapeutic Adjustment Decisions Based on Three-Night Sunrise Recordings and Polysomnography (PSG)
Agreement between therapeutic adjustment decisions derived from three consecutive nights of Sunrise home recordings and in-lab polysomnography (PSG), quantified using Cohen's kappa coefficient. Two independent experts will provide decisions for each modality; disagreements will be resolved by consensus.
The therapeutic decision is a three-category variable: No change in CPAP treatment, adjustment of CPAP pressure or change of mask, switch to servo-ventilation if residual events are predominantly central.
Measured: Three consecutive home nights for Sunrise recordings and one in-lab PSG night.
Agreement Between PSG-Measured rAHI and Sunrise-Measured rAHI (One Night and Three Nights)
This outcome evaluates the concordance between the residual Apnea-Hypopnea Index (rAHI) measured by:
- in-lab polysomnography (PSG) during one night (gold standard),
- the Sunrise device during the first home night,
- the Sunrise device across three consecutive home nights.
For each modality, rAHI values will be interpreted by two independent experts, blinded to the results of the other method.
In case of disagreement between the two experts for a given modality, they will meet to reach a consensus rAHI interpretation, following the same adjudication procedure as for the primary outcome.
The analysis will compare rAHI obtained from PSG with rAHI obtained from Sunrise over one night and over three nights to assess the level of agreement between modalities.
Measured: One in-lab PSG night; one or three consecutive home nights with Sunrise.
Inter-Rater Agreement Between the Two Independent Experts for Therapeutic Adjustment Decisions
For each participant and for each assessment modality (in-lab PSG, one-night Sunrise recording, and three-night Sunrise recording), the therapeutic adjustment decision will be independently provided by Expert 1 and Expert 2, each blinded to the other's evaluation.
The therapeutic decision is a three-category variable:
- No change in CPAP treatment,
- Adjustment of CPAP pressure or change of mask,
- Switch to servo-ventilation if residual events are predominantly central.
This outcome measures the inter-rater agreement between the two experts for each modality, based on their initial independent decisions (before any consensus meeting).
Measured: One in-lab PSG night; one or three consecutive home nights with Sunrise.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2026
- Study start10 Jun 2026
- Primary completionSep 2029 (estimated)
- Study completionSep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Sleep Apnea Syndrome, ObstructiveStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- Polyclinique Saint Laurent - Rennes
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07530302
- Sponsor's protocol ID
- 38RC25.0313
- Acronym
- SUNCPAP
- Status last verified
- Jun 2026
- First submitted
- 30 Mar 2026
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sateia MJ. International classification of sleep disorders-third edition: highlights and modifications. Chest. 2014 Nov;146(5):1387-1394. doi: 10.1378/chest.14-0970.
PubMed 25367475Bland JM, Altman DG. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet. 1986 Feb 8;1(8476):307-10.
PubMed 2868172Cassibba J, Aubertin G, Martinot JB, Le Dong N, Hullo E, Beydon N, Dupont-Athenor A, Mortamet G, Pepin JL. Analysis of mandibular jaw movements to assess ventilatory support management of children with obstructive sleep apnea syndrome treated with positive airway pressure therapies. Pediatr Pulmonol. 2024 Jul;59(7):1905-1911. doi: 10.1002/ppul.27005. Epub 2024 Apr 9.
PubMed 38593278Malhotra A, Martinot JB, Pepin JL. Insights on mandibular jaw movements during polysomnography in obstructive sleep apnea. J Clin Sleep Med. 2024 Jan 1;20(1):151-163. doi: 10.5664/jcsm.10830.
PubMed 37767856Pepin JL, Le-Dong NN, Cuthbert V, Coumans N, Tamisier R, Malhotra A, Martinot JB. Mandibular Movements are a Reliable Noninvasive Alternative to Esophageal Pressure for Measuring Respiratory Effort in Patients with Sleep Apnea Syndrome. Nat Sci Sleep. 2022 Apr 13;14:635-644. doi: 10.2147/NSS.S346229. eCollection 2022.
PubMed 35444480Pepin JL, Cistulli PA, Crespeigne E, Tamisier R, Bailly S, Bruwier A, Le-Dong NN, Lavigne G, Malhotra A, Martinot JB. Mandibular Jaw Movement Automated Analysis for Oral Appliance Monitoring in Obstructive Sleep Apnea: A Prospective Cohort Study. Ann Am Thorac Soc. 2024 May;21(5):814-822. doi: 10.1513/AnnalsATS.202312-1077OC.
PubMed 38330168Kelly JL, Ben Messaoud R, Joyeux-Faure M, Terrail R, Tamisier R, Martinot JB, Le-Dong NN, Morrell MJ, Pepin JL. Diagnosis of Sleep Apnoea Using a Mandibular Monitor and Machine Learning Analysis: One-Night Agreement Compared to in-Home Polysomnography. Front Neurosci. 2022 Mar 15;16:726880. doi: 10.3389/fnins.2022.726880. eCollection 2022.
PubMed 35368281Alsaif SS, Douglas W, Steier J, Morrell MJ, Polkey MI, Kelly JL. Mandibular movement monitor provides faster, yet accurate diagnosis for obstructive sleep apnoea: A randomised controlled study. Clin Med (Lond). 2024 Jul;24(4):100231. doi: 10.1016/j.clinme.2024.100231. Epub 2024 Jul 22.
PubMed 39047815Pepin JL, Woehrle H, Liu D, Shao S, Armitstead JP, Cistulli PA, Benjafield AV, Malhotra A. Adherence to Positive Airway Therapy After Switching From CPAP to ASV: A Big Data Analysis. J Clin Sleep Med. 2018 Jan 15;14(1):57-63. doi: 10.5664/jcsm.6880.
PubMed 29198291Midelet A, Borel JC, Tamisier R, Le Hy R, Schaeffer MC, Daabek N, Pepin JL, Bailly S. Apnea-hypopnea index supplied by CPAP devices: time for standardization? Sleep Med. 2021 May;81:120-122. doi: 10.1016/j.sleep.2021.02.019. Epub 2021 Feb 16.
PubMed 33667996Bottaz-Bosson G, Midelet A, Mendelson M, Borel JC, Martinot JB, Le Hy R, Schaeffer MC, Samson A, Hamon A, Tamisier R, Malhotra A, Pepin JL, Bailly S. Remote Monitoring of Positive Airway Pressure Data: Challenges, Pitfalls, and Strategies to Consider for Optimal Data Science Applications. Chest. 2023 May;163(5):1279-1291. doi: 10.1016/j.chest.2022.11.034. Epub 2022 Dec 2.
PubMed 36470417Pepin JL, Bailly S, Rinder P, Adler D, Szeftel D, Malhotra A, Cistulli PA, Benjafield A, Lavergne F, Josseran A, Tamisier R, Hornus P, On Behalf Of The medXcloud Group. CPAP Therapy Termination Rates by OSA Phenotype: A French Nationwide Database Analysis. J Clin Med. 2021 Mar 1;10(5):936. doi: 10.3390/jcm10050936.
PubMed 33804319Liu D, Armitstead J, Benjafield A, Shao S, Malhotra A, Cistulli PA, Pepin JL, Woehrle H. Trajectories of Emergent Central Sleep Apnea During CPAP Therapy. Chest. 2017 Oct;152(4):751-760. doi: 10.1016/j.chest.2017.06.010. Epub 2017 Jun 16.
PubMed 28629918Levy P, Kohler M, McNicholas WT, Barbe F, McEvoy RD, Somers VK, Lavie L, Pepin JL. Obstructive sleep apnoea syndrome. Nat Rev Dis Primers. 2015 Jun 25;1:15015. doi: 10.1038/nrdp.2015.15.
PubMed 27188535Benjafield AV, Ayas NT, Eastwood PR, Heinzer R, Ip MSM, Morrell MJ, Nunez CM, Patel SR, Penzel T, Pepin JL, Peppard PE, Sinha S, Tufik S, Valentine K, Malhotra A. Estimation of the global prevalence and burden of obstructive sleep apnoea: a literature-based analysis. Lancet Respir Med. 2019 Aug;7(8):687-698. doi: 10.1016/S2213-2600(19)30198-5. Epub 2019 Jul 9.
PubMed 31300334
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Failure of Continuous Positive Airway Pressure (CPAP) in Patients With Obstructive Sleep Apnea Syndrome (OSA): A Randomized Controlled Trial Comparing Polysomnography and the Sunrise Device to Drive Treatment-Adjustment Decisions.
- ClinicalTrials.gov ID
- NCT07530302
- Acronym / sponsor ID
- SUNCPAP / 38RC25.0313
- Conditions
- Sleep Apnea Syndrome, Obstructive
- Keywords
- Obstructive sleep apnea, Randomized, Cross-over, CPAP
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- Polyclinique Saint Laurent - Rennes
- Study start
- 10 Jun 2026 (actual)
- Primary completion
- Sep 2029 (estimated)
- Study completion
- Sep 2029 (estimated)
- First posted
- 15 Apr 2026 (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 goal of this clinical trial is to determine whether treatment-adjustment decisions based on one night of home monitoring with the Sunrise device are comparable to decisions based on one night of in-laboratory polysomnography (PSG) in adults with obstructive sleep apnea (OSA) who remain insufficiently controlled with continuous positive airway pressure (CPAP) therapy.
The main questions it aims to answer are:
- Do Sunrise-based assessments lead to similar therapeutic decisions as PSG-based assessments?
- Are residual apnea-hypopnea indices measured by Sunrise comparable to those measured by PSG?
Participants will complete both assessment sequences in a randomized cross-over design. They will:
- Use the Sunrise device for several nights with and without CPAP.
- Undergo one night of PSG with and without CPAP.
- Have their CPAP therapy reviewed based on the results of each assessment method.
Detailed description
Obstructive sleep apnea (OSA) affects nearly one billion adults worldwide and is associated with recurrent upper-airway obstruction during sleep, leading to intermittent hypoxemia and multiple cardiometabolic and neurocognitive comorbidities. Continuous positive airway pressure (CPAP) is the standard treatment and is widely prescribed, with more than 1.8 million users in France. Despite its proven efficacy, large-scale analyses show that over 10% of treated patients continue to exhibit elevated residual apnea-hypopnea indices (AHI), a situation associated with reduced adherence and premature discontinuation of therapy.
Evaluation of CPAP effectiveness typically relies on in-laboratory polysomnography (PSG), which remains the reference method for characterizing residual respiratory events and sleep architecture. However, the need for PSG generates substantial healthcare costs, long waiting times, and unequal access to diagnostic resources.
The Sunrise device is a CE-marked medical device that records mandibular movements during sleep and uses artificial intelligence to characterize respiratory events and sleep parameters. Multiple validation studies have demonstrated strong agreement between Sunrise-derived metrics and PSG.
This randomized cross-over trial investigates whether Sunrise can be used to guide therapeutic decisions in patients with insufficiently controlled OSA under CPAP therapy, defined by a residual AHI greater than 10 events per hour. Participants are randomized to one of two sequences:
- Sunrise assessments first, consisting of several nights with and without CPAP, followed by one night of PSG with and without CPAP; or
- PSG assessments first, followed by the Sunrise sequence.
This design allows each participant to serve as their own control and enables direct comparison of treatment-adjustment decisions derived from Sunrise versus PSG. The study aims to determine whether a home-based, low-burden assessment could replace or reduce the need for in-laboratory evaluations, thereby improving access to care, reducing costs, and facilitating personalized CPAP management.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PSG-SUN | Other | Device: SunriseParticipants will first undergo an overnight, in-laboratory polysomnography (PSG) in the sleep center. After this in-lab recording period, they will complete an at-home sleep assessment using the Sunrise device over the predefined home recording period. |
| SUN-PSG | Other | Device: SunriseParticipants will first complete an at-home sleep assessment using the Sunrise device over the predefined home recording period. After this home recording period, they will undergo an overnight, in-laboratory polysomnography (PSG) in the sleep center. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults aged 18 to 85 years
- Patients treated with Resmed CPAP
- Residual apnea-hypopnea index under CPAP (rAHI(CPAP) > 10 events/hour)
- Access to a smartphone and home internet connection, and ability to use a mobile application
- Signed informed consent
Key exclusion criteria (9 listed)
- Severe chronic obstructive or restrictive pulmonary disease, with or without supplemental oxygen
- Unstable cardiovascular disease or severe heart failure requiring hospitalization within the past 3 months, or meeting New York Heart Association (NYHA) class III or IV criteria
- Conditions affecting mandibular condyle rotation or temporomandibular joint function
- Refusal to shave excessive facial hair when required for proper placement of the Sunrise device
- Participation in another interventional clinical study or currently within an exclusion period of another 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 |
|---|---|---|
| SunriseThe Sunrise device is a single-use, mandibular movement-based sleep monitoring sensor designed to assess sleep architecture and respiratory events at home. In this study, Sunrise is evaluated as an alternative to in-laboratory polysomnography (PSG), which is considered the current gold-standard reference for sleep assessment. | Device | PSG-SUN, SUN-PSG |
Primary outcome
Cohen's Kappa for Agreement Between Therapeutic Adjustment Decisions Based on Sunrise and Polysomnography (PSG)
Time frame: Within 1 night for each modality (Sunrise home recording and in-lab PSG).
Agreement between therapeutic adjustment decisions derived from Sunrise home recordings and in-lab polysomnography (PSG), quantified using Cohen's kappa coefficient. Two independent experts will provide decisions for each modality; disagreements will be resolved by consensus. The therapeutic decision is a three-category variable: No change in CPAP treatment, adjustment of CPAP pressure or change of mask, switch to servo-ventilation if residual events are predominantly central.
3 secondary outcomes
Cohen's Kappa for Agreement Between Therapeutic Adjustment Decisions Based on Three-Night Sunrise Recordings and Polysomnography (PSG)
Time frame: Three consecutive home nights for Sunrise recordings and one in-lab PSG night.
Agreement Between PSG-Measured rAHI and Sunrise-Measured rAHI (One Night and Three Nights)
Time frame: One in-lab PSG night; one or three consecutive home nights with Sunrise.
Inter-Rater Agreement Between the Two Independent Experts for Therapeutic Adjustment Decisions
Time frame: One in-lab PSG night; one or three consecutive home nights with Sunrise.
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 17 Jun 2026.
- Background: PubMed 25367475Sateia MJ. International classification of sleep disorders-third edition: highlights and modifications. Chest. 2014 Nov;146(5):1387-1394. doi: 10.1378/chest.14-0970.
- Background: PubMed 2868172Bland JM, Altman DG. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet. 1986 Feb 8;1(8476):307-10.
- Background: PubMed 38593278Cassibba J, Aubertin G, Martinot JB, Le Dong N, Hullo E, Beydon N, Dupont-Athenor A, Mortamet G, Pepin JL. Analysis of mandibular jaw movements to assess ventilatory support management of children with obstructive sleep apnea syndrome treated with positive airway pressure therapies. Pediatr Pulmonol. 2024 Jul;59(7):1905-1911. doi: 10.1002/ppul.27005. Epub 2024 Apr 9.
- Background: PubMed 37767856Malhotra A, Martinot JB, Pepin JL. Insights on mandibular jaw movements during polysomnography in obstructive sleep apnea. J Clin Sleep Med. 2024 Jan 1;20(1):151-163. doi: 10.5664/jcsm.10830.
- Background: PubMed 35444480Pepin JL, Le-Dong NN, Cuthbert V, Coumans N, Tamisier R, Malhotra A, Martinot JB. Mandibular Movements are a Reliable Noninvasive Alternative to Esophageal Pressure for Measuring Respiratory Effort in Patients with Sleep Apnea Syndrome. Nat Sci Sleep. 2022 Apr 13;14:635-644. doi: 10.2147/NSS.S346229. eCollection 2022.
- Background: PubMed 38330168Pepin JL, Cistulli PA, Crespeigne E, Tamisier R, Bailly S, Bruwier A, Le-Dong NN, Lavigne G, Malhotra A, Martinot JB. Mandibular Jaw Movement Automated Analysis for Oral Appliance Monitoring in Obstructive Sleep Apnea: A Prospective Cohort Study. Ann Am Thorac Soc. 2024 May;21(5):814-822. doi: 10.1513/AnnalsATS.202312-1077OC.
- Background: PubMed 35368281Kelly JL, Ben Messaoud R, Joyeux-Faure M, Terrail R, Tamisier R, Martinot JB, Le-Dong NN, Morrell MJ, Pepin JL. Diagnosis of Sleep Apnoea Using a Mandibular Monitor and Machine Learning Analysis: One-Night Agreement Compared to in-Home Polysomnography. Front Neurosci. 2022 Mar 15;16:726880. doi: 10.3389/fnins.2022.726880. eCollection 2022.
- Background: PubMed 39047815Alsaif SS, Douglas W, Steier J, Morrell MJ, Polkey MI, Kelly JL. Mandibular movement monitor provides faster, yet accurate diagnosis for obstructive sleep apnoea: A randomised controlled study. Clin Med (Lond). 2024 Jul;24(4):100231. doi: 10.1016/j.clinme.2024.100231. Epub 2024 Jul 22.
- Background: PubMed 29198291Pepin JL, Woehrle H, Liu D, Shao S, Armitstead JP, Cistulli PA, Benjafield AV, Malhotra A. Adherence to Positive Airway Therapy After Switching From CPAP to ASV: A Big Data Analysis. J Clin Sleep Med. 2018 Jan 15;14(1):57-63. doi: 10.5664/jcsm.6880.
- Background: PubMed 33667996Midelet A, Borel JC, Tamisier R, Le Hy R, Schaeffer MC, Daabek N, Pepin JL, Bailly S. Apnea-hypopnea index supplied by CPAP devices: time for standardization? Sleep Med. 2021 May;81:120-122. doi: 10.1016/j.sleep.2021.02.019. Epub 2021 Feb 16.
- Background: PubMed 36470417Bottaz-Bosson G, Midelet A, Mendelson M, Borel JC, Martinot JB, Le Hy R, Schaeffer MC, Samson A, Hamon A, Tamisier R, Malhotra A, Pepin JL, Bailly S. Remote Monitoring of Positive Airway Pressure Data: Challenges, Pitfalls, and Strategies to Consider for Optimal Data Science Applications. Chest. 2023 May;163(5):1279-1291. doi: 10.1016/j.chest.2022.11.034. Epub 2022 Dec 2.
- Background: PubMed 33804319Pepin JL, Bailly S, Rinder P, Adler D, Szeftel D, Malhotra A, Cistulli PA, Benjafield A, Lavergne F, Josseran A, Tamisier R, Hornus P, On Behalf Of The medXcloud Group. CPAP Therapy Termination Rates by OSA Phenotype: A French Nationwide Database Analysis. J Clin Med. 2021 Mar 1;10(5):936. doi: 10.3390/jcm10050936.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sunrise in people with Sleep Apnea Syndrome, Obstructive, run by University Hospital, Grenoble 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 17 Jun 2026. 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 Marie JOYEUX-FAURE, Pr (+33(0)476767166, MJoyeuxfaure@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cohen's Kappa for Agreement Between Therapeutic Adjustment Decisions Based on Sunrise and Polysomnography (PSG) (time frame: Within 1 night for each modality (Sunrise home recording and in-lab PSG).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07530302, which also lists 15 linked publications.
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 17 Jun 2026.