NCT07778121Completed
Screening for Obstructive Sleep Apnea in High-risk Patients in a Danish Rural Population: A Pilot Feasibility Study
Screening for Obstructive Sleep Apnea in High-risk Patients in a Danish Rural Population
Source: ClinicalTrials.gov · Last updated 11 Sept 2026
Brief summary (registry, in English)
Background: Obstructive sleep apnea (OSA) is a sleep disorder characterized by recurrent collapse of the upper airway during sleep, resulting in intermittent hypoxia and fragmented sleep. The condition is more prevalent among individuals with hypertension, atrial fibrillation, type 2 diabetes, and other chronic diseases compared with the general population. Evidence indicates that untreated OSA is associated with adverse health outcomes, whereas treatment of OSA provides significant clinical benefits. However, a substantial proportion of individuals with OSA remain undiagnosed, highlighting the need to improve detection and reduce underdiagnosis. Devices currently used to diagnose OSA are not suitable for screening; however, newer alternatives may be appropriate. The study: This study is a pilot feasibility study. All participants will undergo an interview and examination at a baseline visit and will subsequently use OSA testing devices at home for three consecutive nights. The study includes a questionnaire assessing participants' experience with the devices and technology in general. The objective of this study is to test the feasibility of conducting a study in which adult participants with type 2 diabetes undergo three different home sleep apnea tests over three nights, including issues to be optimized in a subsequent main/definitive study. The main study aims to assess the diagnostic agreement between the devices and will be registered independently.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 43 (actual)
- First submitted
- 14 Jan 2026
- Start date
- 26 Sept 2025
- Primary completion date
- 31 Aug 2026
- Lead sponsor
- Zealand University Hospital
- Diseases
- Type 2 diabetes
- NCT number
- NCT07778121
What you commit to
- Study type: Interventional
- Participants enrolled: 43
- From 26 Sept 2025 to the primary completion date, 31 Aug 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previously undergone surgery for OSA
Other illness
- Clinically suspected of a sleep disorder other than OSA that might compromise the intended purpose of the devices
Other
- Currently or within the last month used treatment for OSA such as CPAP, sleep position trainer, mandibular advancement devices etc.
- Having an Implanted Cardioverter Defibrillator (ICD)
Who the study is looking for
- Age 18 years or above
- Diagnosed with type 2 diabetes mellitus
- Resident in Region Zealand, Denmark
- Understand and speak Danish
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Dept of Otorhinolaryngology, ZUH Køge Coordinator of this site? Confirm its status | Køge | Denmark | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.