Could a breathing machine help you sleep better? new trial investigates
NCT ID NCT07011966
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a breathing therapy device (adaptive servo ventilation) can reduce insomnia severity in adults with moderate to severe chronic insomnia. About 25 participants will use the device and report changes in sleep quality and how long it takes to fall asleep over 4 weeks. The goal is to see if this approach offers a new way to ease insomnia symptoms.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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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
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About 25 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2026
- Expected to finish
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Feb 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide 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: * ≥ 18 years old * Complaint of insomnia when presenting at clinic * Diagnosis of moderate to severe insomnia through the Insomnia Severity Index (ISI) with a score ≥ 15 * Meet diagnostic criteria of Insomnia Disorder (per American Academy of Sleep Medicine) * Naïve to treatment for sleep-disordered breathing (SDB), including CPAP, APAP, ASV; mandibular repositioning devices (MRDs), and any other nasal or oral therapy with a primary indication of treating SDB * Owns a smartphone and is able to install an application for HSAT data syncing. * Able to fully understand study information in English and sign informed consent Exclusion Criteria: * Primary complaint of sleep-disordered breathing or issues with apneas during sleep or excessive daytime sleepiness * Pregnant or planning to be pregnant * Any prior diagnosis of severe respiratory disorder or severe sleep disorder such as restless leg syndrome (RLS), idiopathic hypersomnia, or narcolepsy * High risk for moderate to severe OSA based on STOP-BANG score. * BMI \> 40 kg/m2 * Anticipated changes to start or stop sedative or psychotropic medications during the course of the trial. * Medical history of congestive heart failure (CHF) or other potentially unstable cardiac disease as well as chronic lung diseases or other debilitating medical conditions that manifest as more prominent in the patient's health compared to their sleep complaints. * Daily use of opiate medications * Known contraindications to PAP therapy as listed in the indication for use (i.e. heart failure (NYHA 2-4) with reduced left ventricular ejection fraction (LVEF ≤45%) and moderate to severe predominant central sleep apnea). * Inability to pre-emptively comply with study procedures * Patients who wish to continue using sleeping pills/hypnotics during the study * Patients with conditions affecting the rotation of the condyle in the temporo-mandibular joint.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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C.S. Mott Center
RECRUITINGDetroit, Michigan, 48201, United States
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