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Tests ASV therapy, a device, in adults with primary insomnia

Tests ASV therapy in adults with moderate chronic insomnia.

Key facts

Who runs it
ResMed
Where
Detroit, United StatesSee the site
Trial code
Registry title
ASV Therapy for Insomnia
Status
Recruiting
People taking part
25 people, planned
Started
1 Mar 2026
Expected to end
Feb 2027
Type of study
Interventional
Treatments tested
  • ASV therapy
Record updated
19 May 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with moderate to severe long-term insomnia who have never been treated for sleep-disordered breathing. It tests adaptive servo ventilation (ASV) therapy.

Age
18 years or older
Sex
All sexes can join
Disease stage
Moderate to severe insomnia, with an Insomnia Severity Index (ISI) score of 15 or more, meeting the criteria for Insomnia Disorder
Earlier treatment
Must not have had treatment for sleep-disordered breathing before (CPAP, APAP, ASV, mandibular repositioning devices or other nasal or oral therapy). Must not plan to keep using sleeping pills or hypnotics during the study.

Main reasons for not taking part

  • Main complaint is sleep-disordered breathing, apneas in sleep or excessive daytime sleepiness
  • Pregnant or planning to be pregnant
  • BMI above 40 kg/m2
  • History of congestive heart failure or other unstable heart disease, or chronic lung disease
  • Daily use of opiate medications

The registry criteria, word for word

Show all 19 criteriaShow less

Who can take part

  • ≥ 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

Who cannot take part

  • Any prior diagnosis of severe respiratory disorder or severe sleep disorder such as restless leg syndrome (RLS), idiopathic hypersomnia, or narcolepsy
  • Anticipated changes to start or stop sedative or psychotropic medications during the course of the trial
  • Daily use of opiate medications
  • 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
  • Patients with conditions affecting the rotation of the condyle in the temporo-mandibular joint
  • 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)
  • Primary complaint of sleep-disordered breathing or issues with apneas during sleep or excessive daytime sleepiness
  • Pregnant or planning to be pregnant
  • High risk for moderate to severe OSA based on STOP-BANG score
  • BMI > 40 kg/m2
  • Inability to pre-emptively comply with study procedures
  • Patients who wish to continue using sleeping pills/hypnotics during the study

Where in United States

  • C.S. Mott CenterDetroit, United StatesContact: Karen CollinsTaking people

About the trial

What the trial wants to find out

This will be a single center, prospective study designed to evaluate the effect of adaptive servo ventilation therapy on insomnia severity among patients with moderate to severe chronic insomnia.

The group in the trial

  • ASV TherapyTreatment being tested

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Evaluation of Adaptive Servo Ventilation Therapy for Insomnia Treatment Among Patients With Primary Insomnia
Plain-language title
Tests ASV therapy, a device, in adults with primary insomniaGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
19 May 2026