CPAP vs ASV for Insomnia (P2P)

PAP to PAP: CPAP vs ASV for Insomnia Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Insomnia; Sleep-Disordered Breathing
• Intervention / Treatment: Device: AirCurve 10 ASV

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.

• Study Type: Interventional
• Enrollment (Actual): 78
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Mexico
    • Albuquerque, New Mexico, United States, 87109
      • Maimonides Sleep Arts & Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Continuous Positive Airway Pressure; Continuous positive airway pressure (CPAP) intervention as active comparator. Provides a fixed pressure for both inspiration and expiration.	Device: AirCurve 10 ASV; Device is able to provide both ASV therapy and CPAP therapy modes.; Other Names: VPAP Adapt, AutoSet CS2
Experimental: 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.	Device: AirCurve 10 ASV; Device is able to provide both ASV therapy and CPAP therapy modes.; Other Names: VPAP Adapt, AutoSet CS2

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Insomnia Severity Index	Change in insomnia severity from baseline to 4 months as measured by subjective questionnaire. The Insomnia Severity Index has seven questions. The seven answers are added up for a total score. Scores range from 0 - 28. A higher score indicates a more severe degree of insomnia.	Baseline and 4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep Quality Rating	8 point Likert scale for change in subjective sleep quality from baseline to 4 months. Lower scores indicated more positive sleep quality. A score 0 indicates excellent sleep quality, and a score of 7 indicates very poor sleep quality	Baseline and 4 months
Global Morning Rating	Change in subjective rating from baseline to 4 months based on a 0-100% scale. Lower scores equal a more positive experience	4 months
Sleep Onset Latency	Change in from baseline to 4 months in sleep onset time (minutes)	4 months
Wake After Sleep Onset (WASO)	Change from baseline to 4 months for WASO in minutes	4 months
Sleep Efficiency	Change from baseline to 4 months in sleep efficiency (total sleep time/time in bed)	4 months

Collaborators and Investigators

• Sponsor: ResMed
• Investigators: Principal Investigator: Barry Krakow, MD, Sleep & Human Health Institute

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2015
• Primary Completion (Actual): August 1, 2017
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: February 10, 2015
• First Submitted That Met QC Criteria: February 17, 2015
• First Posted (Estimate): February 18, 2015

Study Record Updates

• Last Update Posted (Actual): September 9, 2021
• Last Update Submitted That Met QC Criteria: August 13, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Apnea Syndromes; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: 682031-1_MA20150206