| NCT ID | NCT07011966 |
| Status | Recruiting |
| Phase | — |
| Sponsor | ResMed |
| Condition | Insomnia |
| Study Type | INTERVENTIONAL |
| Enrollment | 25 participants |
| Start Date | 2026-03-01 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 25 participants in total. It began in 2026-03-01 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07011966 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Insomnia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07011966 currently recruiting?
Yes, NCT07011966 is actively recruiting participants. Contact the research team at daniela.tellez@resmed.com for enrollment information.
Where is the NCT07011966 trial being conducted?
This trial is being conducted at Detroit, United States.
Who is sponsoring the NCT07011966 clinical trial?
NCT07011966 is sponsored by ResMed. The trial plans to enroll 25 participants.
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