ASV Therapy for Insomnia: Can Adaptive Servo Ventilation Help Sleep Loss?

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-center, prospective study to assess the effect of adaptive servo ventilation therapy on insomnia severity in adults with primary insomnia. Participants must have moderate to severe insomnia (ISI ≥ 15) and be naïve to sleep-disordered breathing treatments. Intervention consists of ASV therapy, with data syncing via a smartphone app for HSAT data. The study targets adults who can provide informed consent in English and own a smartphone. Outcomes will focus on changes in insomnia severity and related sleep metrics over the course of treatment.

Why it matters

Who can join: the full rules

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.

Where it's running

• C.S. Mott Center
  Detroit, Michigan, United States Recruiting

Study contacts

• Study coordinator: Daniela Tellez, MPH
• Email: daniela.tellez@resmed.com
• Phone: 858 264 9263

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.