CPAP vs ASV for Insomnia

NCT ID: NCT02365064

Last Updated: 2021-09-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2017-12-01

Brief 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.

Detailed Description

Patients presenting to the sleep clinic with a primary complaint of insomnia will be potential participants for this study. Following diagnostic polysomnography (PSG) testing, insomnia patients diagnosed with SDB and meeting inclusion criteria will be randomized to a PAP treatment arm, CPAP or ASV. Participants will complete titration studies with their assigned PAP mode and attend clinical follow-up appointments over a 14-16 week timeframe. Titration PSG studies will assess PAP pressure needs to ensure that patients are receiving optimal therapy at all times during this study. PAP adaptation barriers will be addressed as they arise during the study, because it is important that participants are able to use PAP therapy nightly during participation in this protocol. Baseline scores on insomnia severity, sleep quality, subjective insomnia parameters, sleep related impairment, and quality of life will be compared to outcome measures at the 4 month mark. Pre-treatment and post-treatment objective improvements on sleep studies will also be compared including sleep breathing indices, sleep consolidation indices, and objective data download information.

Conditions

Insomnia; Sleep-Disordered Breathing

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Continuous Positive Airway Pressure

Continuous positive airway pressure (CPAP) intervention as active comparator. Provides a fixed pressure for both inspiration and expiration.

Group Type: ACTIVE_COMPARATOR

AirCurve 10 ASV

Intervention Type: DEVICE

Device is able to provide both ASV therapy and CPAP therapy modes.

Adaptive Servo-Ventilation

Adaptive servo-ventilation (ASV) positive airway pressure as experimental intervention. Provides a higher pressure for inspiration and a lower pressure for expiration with changes in the pressure support level to meet a target minute ventilation.

Group Type: EXPERIMENTAL

AirCurve 10 ASV

Intervention Type: DEVICE

Device is able to provide both ASV therapy and CPAP therapy modes.

Interventions

AirCurve 10 ASV

Device is able to provide both ASV therapy and CPAP therapy modes.

Intervention Type: DEVICE

Other Intervention Names

VPAP Adapt, AutoSet CS2

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 < 5 events/hour
• 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
• 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
• Severe respiratory disorder or severe sleep disorder such as restless leg syndrome (RLS), idiopathic hypersomnia, or narcolepsy
• BMI > 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ResMed

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Barry Krakow, MD

Role: PRINCIPAL_INVESTIGATOR

Sleep & Human Health Institute

Locations

Maimonides Sleep Arts & Sciences

Albuquerque, New Mexico, United States

Countries

United States

References

Krakow B, McIver ND, Ulibarri VA, Krakow J, Schrader RM. Prospective Randomized Controlled Trial on the Efficacy of Continuous Positive Airway Pressure and Adaptive Servo-Ventilation in the Treatment of Chronic Complex Insomnia. EClinicalMedicine. 2019 Aug 8;13:57-73. doi: 10.1016/j.eclinm.2019.06.011. eCollection 2019 Aug.

Reference Type: DERIVED

PMID: 31517263 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

682031-1_MA20150206

Identifier Type: -

Identifier Source: org_study_id