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Can a simple home test catch hidden sleep apnea in diabetes?

NCT ID NCT07778121

Diagnosis Sponsor: Zealand University Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 21, 2026 · Last updated Sep 04, 2026 · Updated 1 time

Summary

This pilot study explores whether three different home sleep apnea testing devices—NightOwl, SleepImage, and Nox T3—are practical and user-friendly for adults with type 2 diabetes. Participants will wear each device at home for three nights and answer questionnaires about their experience. The goal is to see if these devices could be used for screening in a larger study, potentially helping to detect undiagnosed sleep apnea earlier.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Home sleep apnea testing with NightOwl, SleepImage, and Nox T3 devices
What this could lead to
If successful, this could lead to a practical, at-home screening method to detect obstructive sleep apnea earlier in people with type 2 diabetes, potentially improving health outcomes.
What could go wrong
This is a small pilot study focused on feasibility, not diagnostic accuracy. The devices may not be comfortable or reliable enough for widespread use, and results may not apply to broader populations.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2025

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

obstructive sleep apnea syndrome type 2 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Obstructive sleep apnea (OSA) Type 2 diabetes

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Dept of Otorhinolaryngology, ZUH Køge

    RECRUITING

    Køge, 4600, Denmark

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