Type 2 DiabetesNCT07778121
Screening for Obstructive Sleep Apnea in High-risk Patients in a Danish Rural Population: A Pilot Feasibility Study
A study testing Home Sleep Apnea Test in people with Type 2 Diabetes and Obstructive Sleep Apnea (OSA), run by Zealand University Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes, Obstructive Sleep Apnea (OSA)
- What is being tested?
- Home Sleep Apnea Test
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteDenmark
- Study dates
- 26 Sep 2025to 31 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 years or above
- Diagnosed with type 2 diabetes mellitus
- Resident in Region Zealand, Denmark
- Understand and speak Danish
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Screening for Obstructive Sleep Apnea in High-risk Patients in a Danish Rural Population
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.
Read more
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
- Type 2 Diabetes, Obstructive Sleep Apnea (OSA)
- Being tested
- Home Sleep Apnea Test
- 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
- Medical subject headings
- Diabetes Mellitus, Type 2, Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home Sleep Apnea TestDevice
Home sleep apnea testing with NightOwl, SleepImage and Nox T3
| Study group | Role | What they receive |
|---|---|---|
| Pilot study | Experimental | Single-arm testing the feasibility of conducting a clinical trial testing three different home sleep apnea tests in patients with type 2 diabetes. Receives: Device: Home Sleep Apnea Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant-Reported Experience with the NightOwl Device
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.
Measured: Day 3 (after two nights of home monitoring, before the third night).
Participant-Reported Experience with the SleepImage Device
Assessed identically to Outcome 1 for the SleepImage Device.
Measured: Day 3 (after two nights of home monitoring, before the third night).
Proportion of Analyzable Recordings by Device
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.
Measured: Through completion of home monitoring for each participant (three analyzable nights obtained or further attempts declined), up to 12 weeks after enrollment
Secondary outcomes (6)
Inclusion rate
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.
Measured: Through study completion, an average of one month
Recruitment Source Distribution
Proportion of participants enrolled via each recruitment route (diabetes outpatient clinic, general practice, patient-organisation/social media), reported as frequencies.
Measured: Assessed after inclusion of the last participant
Proportion of Participants Obtaining Three Nights With Analyzable Recordings
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.
Measured: Through completion of home monitoring for each participant (three analyzable nights obtained or further attempts declined), up to 12 weeks after enrollment
Additional Test Nights Required to Obtain Three Analyzable Nights Among Participants Completing Home Monitoring
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.
Measured: Through completion of home monitoring for each participant (three analyzable nights obtained or further attempts declined), up to 12 weeks after enrollment
Number of Test Night Attempts Before Participant Discontinuation
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.
Measured: Through completion of home monitoring for each participant (three analyzable nights obtained or further attempts declined), up to 12 weeks after enrollment
Completeness of Baseline Assessments
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).
Measured: Baseline (first visit).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2026
- Study start26 Sep 2025
- Primary completion31 Aug 2026
- Study completion31 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Zealand University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zealand University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Novo Nordic Foundation, Steno Diabetes Center Sjaelland
- Responsible party
- Principal investigator, Preben Homøe, Zealand University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07778121
- Sponsor's protocol ID
- p-2024-16547
- Other IDs
- 2403689
- Status last verified
- Sep 2026
- First submitted
- 14 Jan 2026
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: In agreement with GDPR and Danish legislation
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening for Obstructive Sleep Apnea in High-risk Patients in a Danish Rural Population
- ClinicalTrials.gov ID
- NCT07778121
- Acronym / sponsor ID
- p-2024-16547
- Conditions
- Type 2 Diabetes, Obstructive Sleep Apnea (OSA)
- Keywords
- Home Sleep Apnea Test, HSAT, NightOwl, SleepImage, OSA, Obstructive Sleep Apnea, Type 2 Diabetes, Peripheral Arterial Tonometry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Zealand University HospitalUniversity, hospital or other
- Collaborators
- The Novo Nordic Foundation, Steno Diabetes Center Sjaelland
- Study start
- 26 Sep 2025 (actual)
- Primary completion
- 31 Aug 2026 (actual)
- Study completion
- 31 Aug 2026 (actual)
- First posted
- 21 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pilot study | Experimental | Device: Home Sleep Apnea TestSingle-arm testing the feasibility of conducting a clinical trial testing three different home sleep apnea tests in patients with type 2 diabetes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 years or above
- Diagnosed with type 2 diabetes mellitus
- Resident in Region Zealand, Denmark
- Understand and speak Danish
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home Sleep Apnea TestHome sleep apnea testing with NightOwl, SleepImage and Nox T3 | Device | Pilot study |
Primary outcome
Participant-Reported Experience with the NightOwl Device
Time frame: 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
Time frame: 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
Time frame: 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.
6 secondary outcomes
Inclusion rate
Time frame: Through study completion, an average of one month
Recruitment Source Distribution
Time frame: Assessed after inclusion of the last participant
Proportion of Participants Obtaining Three Nights With Analyzable Recordings
Time frame: Through completion of home monitoring for each participant (three analyzable nights obtained or further attempts declined), up to 12 weeks after enrollment
Additional Test Nights Required to Obtain Three Analyzable Nights Among Participants Completing Home Monitoring
Time frame: Through completion of home monitoring for each participant (three analyzable nights obtained or further attempts declined), up to 12 weeks after enrollment
Number of Test Night Attempts Before Participant Discontinuation
Time frame: Through completion of home monitoring for each participant (three analyzable nights obtained or further attempts declined), up to 12 weeks after enrollment
Completeness of Baseline Assessments
Time frame: Baseline (first visit).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Individual participant dataSharing planned: No. In agreement with GDPR and Danish legislation
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home Sleep Apnea Test in people with Type 2 Diabetes and Obstructive Sleep Apnea (OSA), run by Zealand University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant-Reported Experience with the NightOwl Device (time frame: Day 3 (after two nights of home monitoring, before the third night).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.