NCT07011966Recruiting
ASV Therapy for Insomnia
Evaluation of Adaptive Servo Ventilation Therapy for Insomnia Treatment Among Patients With Primary Insomnia
Source: ClinicalTrials.gov · Last updated 19 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 25 (estimated)
- First submitted
- 2 Jun 2025
- Start date
- 1 Mar 2026
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- ResMed
- NCT number
- NCT07011966
What you commit to
- Study type: Interventional
- Planned participants: 25
- From 1 Mar 2026 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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.
Lab values
- 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).
Other
- 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
Who the study is looking for
- ≥ 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| C.S. Mott Center Coordinator of this site? Confirm its status | Detroit | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.