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TrialNCT07778121

Screening for Obstructive Sleep Apnea in High-risk Patients in a Danish Rural Population: A Pilot Feasibility Study

Status
RECRUITING
Phase
NA
Last update posted
09/04/2026
Start
10/20/2025
Sponsor
Zealand University Hospital
Specialties
cardiology, diabetes, family-medicine

Conditions: Type 2 Diabetes; Obstructive Sleep Apnea (OSA)

Brief summary

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.

Protocol documents and results are not hosted here. Verify every detail on ClinicalTrials.gov.

Clinical Evidence