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

NCT07778121 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-08-21

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

Home Sleep Apnea Test

Home sleep apnea testing with NightOwl, SleepImage and Nox T3

Sponsors & Collaborators

  • The Novo Nordic Foundation

    collaborator OTHER

  • Steno Diabetes Center Sjaelland

    collaborator OTHER_GOV

  • Zealand University Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-10-20
Primary Completion
2026-09-01
Completion
2026-10-01
FDA Device
Yes

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07778121 on ClinicalTrials.gov