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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• Age 18 years or above

• Diagnosed with type 2 diabetes mellitus

• Resident in Region Zealand, Denmark

• Understand and speak Danish

Locations
Other Locations
Denmark
Dept of Otorhinolaryngology, ZUH Køge
RECRUITING
Køge
Contact Information
Primary
Mathilde Kjeldsen, MD, PhD student
matkj@regionsjaelland.dk
+ 45 25 83 13 55
Backup
Preben Homøe, MD, PhD, DMSc
prho@regionsjaelland.dk
+ 45 47 32 96 09
Time Frame
Start Date: 2025-10-20
Estimated Completion Date: 2026-10-01
Participants
Target number of participants: 40
Treatments
Experimental: Pilot study
Single-arm testing the feasibility of conducting a clinical trial testing three different home sleep apnea tests in patients with type 2 diabetes.
Sponsors
Collaborators: The Novo Nordic Foundation, Steno Diabetes Center Sjaelland
Leads: Zealand University Hospital

This content was sourced from clinicaltrials.gov