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ASV Therapy for Insomnia

This study is looking at how a device called Adaptive Servo Ventilation (ASV) therapy, specifically using the ResMed AirCurve 11 device, might help people with moderate to severe insomnia. The ASV device is already approved for treating sleep apnea. You might be able to join if you are at least 18 years old, have a complaint of insomnia, and have been diagnosed with moderate to severe insomnia. You also cannot have received treatment for sleep-disordered breathing before. The researchers will measure your insomnia severity using a score called the Insomnia Severity Index (ISI) after 4 weeks to see if the ASV therapy is effective. The current recruitment status is unclear.

Study design
This is an interventional study planning to enroll 25 participants. It is a single-center, prospective study.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured at 4 weeks after therapy starts.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07011966

ASV Therapy for Insomnia

Recruiting
NAAges 18+InterventionalTreatment
ResMed
~25 participants
Updated 2026-05-19 on ClinicalTrials.gov
What's tested:ASV therapy

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Insomnia Severity Index (ISI) score
Measured over 4 weeks after therapy start

Conditions

Insomnia
Insomnia (Moderate)

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Insomnia

Where it's being run

1 sites across 1 states
Michigan1

Who to contact

Daniela Tellez, MPH
[email protected]
858 264 9263
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

≥ 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

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.

What this trial measures

  • Insomnia Severity Index (ISI) score4 weeks after therapy start

    Change in insomnia severity from baseline to 4 weeks after treatment initiation, as measured by subjective questionnaire