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

RecruitingNA

Sponsor: Zealand University Hospital

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

Interventions: Home Sleep Apnea Test

Countries: Denmark

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Age 18 years or above
* Diagnosed with type 2 diabetes mellitus
* Resident in Region Zealand, Denmark
* Understand and speak Danish

Exclusion Criteria:

* Previously undergone surgery for OSA
* 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)
* Clinically suspected of a sleep disorder other than OSA that might compromise the intended purpose of the devices

Locations (1)

Køge, Denmark