Evaluation of Adaptive Servo Ventilation Therapy for Insomnia Treatment Among Patients With Primary Insomnia
ResMed
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.
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
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 i…
Interventions
- DeviceASV 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.
Location
- C.S. Mott CenterDetroit, Michigan