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RECRUITING
NCT07778121
NA

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

Sponsor: Zealand University Hospital

View on ClinicalTrials.gov

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.

Official title: Screening for Obstructive Sleep Apnea in High-risk Patients in a Danish Rural Population

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2025-10-20

Completion Date

2026-10-01

Last Updated

2026-09-04

Healthy Volunteers

Yes

Interventions

DEVICE

Home Sleep Apnea Test

Home sleep apnea testing with NightOwl, SleepImage and Nox T3

Locations (1)

Dept of Otorhinolaryngology, ZUH Køge

Køge, Denmark