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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
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

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Dept of Otorhinolaryngology, ZUH Køge
Coordinator of this site? Confirm its status
KøgeDenmarkUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.