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.

NCT07530302 | Not Yet Recruiting

• 1 other identifier: 38RC25.0313
• Study Type: interventional
• Target: 105
• Locations: 0 countries
• Sites: N/A

Brief 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 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.

Conditions

Sleep Apnea Syndrome, Obstructive

Keywords

Obstructive sleep apnea; Randomized; Cross-over; CPAP

Outcome Measures

Primary Outcomes (1)

• 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.

  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)

  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)

  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

  One in-lab PSG night; one or three consecutive home nights with Sunrise.

Study Arms (2)

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.

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.

Device: Sunrise

Interventions

Sunrise DEVICE

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.

PSG-SUN; SUN-PSG

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Individuals who, in the investigator's judgment, are unlikely to comply with study procedures or requirements
• 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

Sponsors & Collaborators

• University Hospital, Grenoble: lead
• Polyclinique Saint Laurent - Rennes: collaborator

Related Publications (15)

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• Pepin 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.

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MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Central Study Contacts

Marie JOYEUX-FAURE, Pr

CONTACT

+33(0)476767166; MJoyeuxfaure@chu-grenoble.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2026
• First Posted: April 15, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share