Clinical trial NCT07011966: ASV Therapy for Insomnia
Official title: Evaluation of Adaptive Servo Ventilation Therapy for Insomnia Treatment Among Patients With Primary Insomnia
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Insomnia
Insomnia (Moderate)
Keywords: Insomnia
ASV
PAP
Lead sponsor: ResMed
Sponsor class: INDUSTRY
First posted: 2025-06-10
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: The primary objective of the study is to evaluate the effectiveness of adaptive servo ventilation therapy to reduce insomnia severity in primary insomnia patients.

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.

Primary outcomes:
measure: Insomnia Severity Index (ISI) score
timeFrame: 4 weeks after therapy start
Secondary outcomes:
measure: Sleep Onset Latency
timeFrame: 4 weeks after treatment initiation
Other outcomes:
Locations:
city: Detroit
country: United States
facility: C.S. Mott Center
state: Michigan
Study officials:
References: