Obstructive Sleep Apnea (OSA), Type 2 Diabetes
Conditions
Keywords
Home Sleep Apnea Test, HSAT, NightOwl, SleepImage, OSA, Obstructive Sleep Apnea, Type 2 Diabetes, Peripheral Arterial Tonometry, Cardiopulmonary coupling, Screening, Feasibility, Pilot, Nox T3, Cardiorespiratory Monitor
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.
Interventions
DEVICEHome Sleep Apnea Test
Home sleep apnea testing with NightOwl, SleepImage and Nox T3
Sponsors
Zealand University Hospital
The Novo Nordic Foundation
Steno Diabetes Center Sjaelland
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participant-Reported Experience with the NightOwl Device | Day 3 (after two nights of home monitoring, before the third night). | Participant-reported experience with the NightOwl device, assessed at Day 3 with a study-specific questionnaire. Items are rated on a 0-100 visual analog scale (0 = completely disagree, 100 = completely agree) and span four dimensions: 1) device usability (overall ease of use, learnability, adequacy of information, adherence to instructions, interference with daily life, sleep disturbance), 2) sensor application and overnight fit, 3) smartphone-application comprehensibility and ease of use, and 4) confidence in measurement and perceived health empowerment. Reported as median (range) per dimension, and as an overall median score. |
| Participant-Reported Experience with the SleepImage Device | Day 3 (after two nights of home monitoring, before the third night). | Assessed identically to Outcome 1 for the SleepImage Device. |
| Proportion of Analyzable Recordings by Device | Through completion of home monitoring for each participant (three analyzable nights obtained or further attempts declined), up to 12 weeks after enrollment | For each device (NightOwl, SleepImage, Nox T3), the number of nights yielding an analyzable recording meeting predefined technical criteria, divided by the number of nights the device was worn, expressed as a percentage. The complementary proportion of failed, incomplete, or non-analyzable recordings is reported per device. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Inclusion rate | Through study completion, an average of one month | Number of enrolled participants divided by the duration of the recruitment period, expressed as participants per month. The recruitment period is defined as the time from enrollment of the first participant to enrollment of the last participant. |
| Recruitment Source Distribution | Assessed after inclusion of the last participant | Proportion of participants enrolled via each recruitment route (diabetes outpatient clinic, general practice, patient-organisation/social media), reported as frequencies. |
| Proportion of Participants Obtaining Three Nights With Analyzable Recordings | Through completion of home monitoring for each participant (three analyzable nights obtained or further attempts declined), up to 12 weeks after enrollment | Number of participants obtaining three nights of home monitoring with analyzable recordings from all devices scheduled for each night (NightOwl and SleepImage on nights 1-2; NightOwl, SleepImage and Nox T3 on night 3), divided by the number enrolled, expressed as a percentage. |
| Additional Test Nights Required to Obtain Three Analyzable Nights Among Participants Completing Home Monitoring | Through completion of home monitoring for each participant (three analyzable nights obtained or further attempts declined), up to 12 weeks after enrollment | Among participants obtaining three nights with analyzable recordings from all devices scheduled for that night, the total number of home monitoring nights attempted. A night is repeated with all scheduled devices if the recording from one or more of these devices fails, is incomplete, or is non-analyzable, as assessed against predefined technical criteria. Reported as mean (SD) and median (range) nights attempted, and as the proportion of these participants requiring more than three nights. Participants declining further attempts before three analyzable nights were obtained are reported under outcome 8. |
| Number of Test Night Attempts Before Participant Discontinuation | Through completion of home monitoring for each participant (three analyzable nights obtained or further attempts declined), up to 12 weeks after enrollment | Among participants who declined further attempts before three analyzable nights were obtained, the number of nights attempted at discontinuation. Reported as mean (SD) and median (range) attempts, together with the number and proportion of enrolled participants discontinuing before obtaining three analyzable nights. This outcome and outcome 7 comprise complementary, mutually exclusive groups, together accounting for all participants who started home monitoring. |
| Completeness of Baseline Assessments | Baseline (first visit). | Completeness of planned baseline assessments, reported as the proportion of participants with fully complete baseline data across all assessments and as the proportion completed per individual assessment (Berlin Questionnaire, STOP-Bang, Epworth Sleepiness Scale, ENT examination with flexible endoscopy, measuremen neck, waist and hip circumference, autonomic neuropathy assessment, blood pressure, lipids, HbA1c). |
Countries
Denmark
Outcome results
None listed