Recruiting

Adaptive Servo Ventilation

Sponsor:

ResMed

Code:

NCT07011966

Conditions

Insomnia

Insomnia (Moderate)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

ASV therapy

Study Details

Brief summary:

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.

Conditions

Insomnia

Insomnia (Moderate)

Study ID

NCT07011966

Start date

Mar 1, 2026

Status verified date

May, 2026

Completion date

Feb, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

25 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: ASV Therapy

Interventions

ASV therapy

Adaptive servo ventilation (ASV) therapy using ResMed AirCurve 11 device will be used to target potential upper airway resistance and respiratory related arousals in patients with insomnia. The ASV device is approved for the treatment of obstructive sleep apnea, and this will be designated as the investigational device for this study with appropriate labelling.

Primary outcome measure

  • Insomnia Severity Index (ISI) score [ Time Frame: 4 weeks after therapy start ]

Central Contacts and Locations

Central contacts

Daniela Tellez, MPH

858 264 9263daniela.tellez@resmed.com

Locations

C.S. Mott Center

Recruiting

Detroit, Michigan, United States, 48201

Contacts

Karen Collins

313-577-8606kcollins@med.wayne.edu

More Information

Sponsor

ResMed

Last update posted

May 19, 2026

Last verified

May, 2026

Keywords

  • Insomnia
  • ASV
  • PAP

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by ResMed on 2026-05-19.