N/A N=78 Randomized Single-blind Treatment

CPAP vs ASV for Insomnia

Insomnia · Sleep-Disordered Breathing

Bottom Line

View on ClinicalTrials.gov: NCT02365064 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2021

Primary outcome: Primary: Insomnia Severity Index — 9.29; 13.21 units on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: AirCurve 10 ASV (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: ResMed
Primary completion: Aug 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Insomnia Severity Index	9.29; 13.21	—
SECONDARY Sleep Quality Rating	1.06; 1.65	—
SECONDARY Global Morning Rating	15.39; 24.33	—
SECONDARY Sleep Onset Latency	-6.09; 7.17	—
SECONDARY Wake After Sleep Onset (WASO)	5.72; -0.12	—
SECONDARY Sleep Efficiency	0.75; -2.85	—

Summary

The study will determine which of two different types of positive airway pressure (PAP therapy) modes are more effective in reducing sleep breathing events in chronic insomnia patients and in decreasing insomnia severity.

Eligibility Criteria

Inclusion Criteria

Primary 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)
Diagnosis of SDB, either OSA as determined by an AHI ≥ 5 events/hour or UARS with a RDI ≥ 15 events/hour and AHI 30 kg/m2
Epworth Sleepiness Scale (ESS) score ≥ 10
Frequent napping behavior, such as a few times a week or more
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
Requires a CPAP (fixed) pressure > 20 cm H2O
Inability to comply with study procedures

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02365064). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.