Sleep Disorder; Breathing-RelatedNCT07363070
Adherence to Chronic Positive Airway Pressure Therapy in Obese Patients With Sleep-disordered Breathing
An observational study of Sleep Disorder; Breathing-Related and Obesity, run by Anne Kathrine Staehr-Rye at 1 site in Denmark.
Trial summary
To describe the adherence to positive airway pressure therapy among obese adult patients refered to the respiratory center east Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Disorder; Breathing-Related, Obesity, Adherence, Treatment
- What is being tested?
- Positive Airway Pressure Therapy
- Type of treatment
- Medical device
- How many people
- 300 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jan 2021to 1 Jan 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Respiratory center east,
Who may be able to join
- 18 years or older
- Body mass index above 30 kg/m2
- Referred to the Respiratory Center East between january 2021 and january 2024
Who cannot join
- Neuromuscular disease
- Spinal cord injury
- Craniofacial malformation
- Scoliosis
- Diaphragmatic paresis
- Referred to profylactic secrete management only
- Already in treatment with nPAP with use of nPAP a minimum of 4 hours per night for 70% of the time within a consecutive 30-day period during the last 90 days.
- No medical indication for start of nPAP.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Respiratory Center East, Rigshospitalet
Glostrup Municipality, 2600
About this study
To describe the adherence to positive airway pressure therapy among obese adult patients refered to the respiratory center east
- Being tested
- Positive Airway Pressure Therapy
- Medical subject headings
- Sleep Wake Disorders, Obesity, Treatment Adherence and Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positive Airway Pressure TherapyDevice
Use of Positive Airway Pressure Therapy
Positive Airway Pressure TherapyDevice
Use of chronic positive Airway Pressure Therapy
What is being measured
The primary outcome is the main question the study is designed to answer.
Compliance to noninvasive positive airway pressure therapy (nPAP) - 90 days
Use of nPAP a minimum of 4 hours per night for 70% of the time within a consecutive 30-day period within the first 90 days of having the equipment.
Measured: 0-3 months after start of noninvasive positive airway pressure therapy
Secondary outcomes (2)
Mortality
Mortality up to 1 year after initiation of noninvasive positive airway pressure therapy
Measured: 1 year
Compliance to noninvasive positive airway pressure therapy (nPAP) - 1 year
Use of nPAP a minimum of 4 hours per night for 70% of the time within a consecutive 30-day period within the 275 to 365 day of having the equipment.
Measured: Time Frame: 275 to 365 day after start of noninvasive positive airway pressure therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2026
- Study start1 Jan 2021
- Primary completion1 Apr 2025
- Study completion1 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Disorder; Breathing-RelatedStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anne Kathrine Staehr-Rye
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Anne Kathrine Staehr-Rye, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07363070
- Sponsor's protocol ID
- p-2025-20420
- Status last verified
- Jan 2026
- First submitted
- 2 Jan 2026
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adherence to Chronic Positive Airway Pressure Therapy in Obese Patients With Sleep-disordered Breathing
- ClinicalTrials.gov ID
- NCT07363070
- Acronym / sponsor ID
- p-2025-20420
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Anne Kathrine Staehr-RyeUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- 1 Jan 2026 (actual)
- First posted
- 23 Jan 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.
To describe the adherence to positive airway pressure therapy among obese adult patients refered to the respiratory center east
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Respiratory center east,
Key inclusion criteria (3 listed)
- 18 years or older
- Body mass index above 30 kg/m2
- Referred to the Respiratory Center East between january 2021 and january 2024
Key exclusion criteria (8 listed)
- Neuromuscular disease
- Spinal cord injury
- Craniofacial malformation
- Scoliosis
- Diaphragmatic paresis
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 |
|---|---|---|
| Positive Airway Pressure TherapyUse of Positive Airway Pressure Therapy | Device | – |
| Positive Airway Pressure TherapyUse of chronic positive Airway Pressure Therapy | Device | – |
Primary outcome
Compliance to noninvasive positive airway pressure therapy (nPAP) - 90 days
Time frame: 0-3 months after start of noninvasive positive airway pressure therapy
Use of nPAP a minimum of 4 hours per night for 70% of the time within a consecutive 30-day period within the first 90 days of having the equipment.
2 secondary outcomes
Mortality
Time frame: 1 year
Compliance to noninvasive positive airway pressure therapy (nPAP) - 1 year
Time frame: Time Frame: 275 to 365 day after start of noninvasive positive airway pressure therapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Sleep Disorder; Breathing-Related and Obesity, run by Anne Kathrine Staehr-Rye at 1 site in Denmark.
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 3 inclusion and 8 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: finished, as of the sponsor's last update on 23 Jan 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 Denmark. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compliance to noninvasive positive airway pressure therapy (nPAP) - 90 days (time frame: 0-3 months after start of noninvasive positive airway pressure therapy). 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 23 Jan 2026.