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Compares treatment options for Sleep Apnea Syndrome, Obstructive
Official title 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.
ClinicalTrials.gov ID: NCT07530302
What this study is testing
- What it's testing
- 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?
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85
You may be able to join 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
You likely can't join 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...
- 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 treatment 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
See the full eligibility criteria
- 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
- 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 treatment 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
- 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...
- Staff members with a hierarchical relationship to the principal investigator
The study team makes the final eligibility decision.
Where it's taking place
- Grenoble, France
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Grenoble, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.