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RecruitingInsomniaInsomnia (Moderate)

ASV Therapy for Insomnia

Eligible age

18+ yrs

Accepts

All genders

Locations

1 state

Healthy volunteers

No

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About this study

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.

Sponsor: ResMed

You may qualify if…

  • ≥ 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

You may not qualify if…

  • 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

Where it's recruiting

Michigan

Detroit

Source: ClinicalTrials.gov · NCT07011966 · last updated 2026-05-19

ASV Therapy for Insomnia · TrialPath