- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07363070
Adherence to Chronic Positive Airway Pressure Therapy in Obese Patients With Sleep-disordered Breathing
January 15, 2026 updated by: Anne Kathrine Staehr-Rye
To describe the adherence to positive airway pressure therapy among obese adult patients refered to the respiratory center east
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
300
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Glostrup Municipality, Denmark, 2600
- Respiratory Center East, Rigshospitalet
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Respiratory center east,
Description
Inclusion Criteria:
- 18 years or older
- Body mass index above 30 kg/m2
- Referred to the Respiratory Center East between january 2021 and january 2024
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
0-3 months after start of noninvasive positive airway pressure therapy
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mortality
Time Frame: 1 year
|
Mortality up to 1 year after initiation of noninvasive positive airway pressure therapy
|
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
|
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.
|
Time Frame: 275 to 365 day after start of noninvasive positive airway pressure therapy
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2021
Primary Completion (Actual)
April 1, 2025
Study Completion (Actual)
January 1, 2026
Study Registration Dates
First Submitted
January 2, 2026
First Submitted That Met QC Criteria
January 15, 2026
First Posted (Actual)
January 23, 2026
Study Record Updates
Last Update Posted (Actual)
January 23, 2026
Last Update Submitted That Met QC Criteria
January 15, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neurologic Manifestations
- Nervous System Diseases
- Mental Disorders
- Nutrition Disorders
- Overnutrition
- Body Weight
- Overweight
- Pathological Conditions, Signs and Symptoms
- Behavior
- Nutritional and Metabolic Diseases
- Signs and Symptoms
- Health Behavior
- Obesity
- Sleep Wake Disorders
- Treatment Adherence and Compliance
Other Study ID Numbers
- p-2025-20420
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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