ASV Therapy for Insomnia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorResMed
About this trial
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
This trial does not accept healthy volunteersQualifiers
≥ 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)
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
ASV therapy
DeviceAdaptive 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.
Treatment groups
25 Participants
are divided into 1 treatment groupGroup A: ASV TherapyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Insomnia Severity Index (ISI) score
Change in insomnia severity from baseline to 4 weeks after treatment initiation, as measured by subjective questionnaire
Time frame
4 weeks after therapy startSecondary outcomes
1
Sleep Onset Latency
Change in from baseline to end of treatment in sleep onset time
Time frame
4 weeks after treatment initiation Source ClinicalTrials.gov