Back to results

CPAP vs ASV for Insomnia (P2P)

Primary Purpose

Insomnia, Sleep-Disordered Breathing

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

AirCurve 10 ASV

About this trial

This is an interventional treatment trial for Insomnia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Maimonides Sleep Arts & Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Continuous Positive Airway Pressure

Adaptive Servo-Ventilation

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

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

Sleep Onset Latency

Change in from baseline to 4 months in sleep onset time (minutes)

Wake After Sleep Onset (WASO)

Change from baseline to 4 months for WASO in minutes

Sleep Efficiency

Change from baseline to 4 months in sleep efficiency (total sleep time/time in bed)

Full Information

NCT ID

NCT02365064

First Posted

February 10, 2015

Last Updated

August 13, 2021

Sponsor

ResMed

1. Study Identification

Unique Protocol Identification Number

NCT02365064

Brief Title

CPAP vs ASV for Insomnia

Acronym

P2P

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2021

Overall Recruitment Status

Completed

Study Start Date

February 2015 (Actual)

Primary Completion Date

August 2017 (Actual)

Study Completion Date

December 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

ResMed

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Insomnia, Sleep-Disordered Breathing

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

78 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Continuous Positive Airway Pressure

Arm Type

Active Comparator

Arm Description

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

Arm Title

Adaptive Servo-Ventilation

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

AirCurve 10 ASV

Other Intervention Name(s)

VPAP Adapt, AutoSet CS2

Intervention Description

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

Primary Outcome Measure Information:

Title

Insomnia Severity Index

Description

Time Frame

Baseline and 4 months

Secondary Outcome Measure Information:

Title

Sleep Quality Rating

Description

Time Frame

Baseline and 4 months

Title

Global Morning Rating

Description

Change in subjective rating from baseline to 4 months based on a 0-100% scale. Lower scores equal a more positive experience

Time Frame

4 months

Title

Sleep Onset Latency

Description

Change in from baseline to 4 months in sleep onset time (minutes)

Time Frame

4 months

Title

Wake After Sleep Onset (WASO)

Description

Change from baseline to 4 months for WASO in minutes

Time Frame

4 months

Title

Sleep Efficiency

Description

Change from baseline to 4 months in sleep efficiency (total sleep time/time in bed)

Time Frame

4 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Barry Krakow, MD

Organizational Affiliation

Sleep & Human Health Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Maimonides Sleep Arts & Sciences

City

Albuquerque

State/Province

New Mexico

ZIP/Postal Code

87109

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

31517263

Citation

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.

Results Reference

derived

Learn more about this trial

CPAP vs ASV for Insomnia

We'll reach out to this number within 24 hrs