CPAP vs ASV for Insomnia
P2P
PAP to PAP: CPAP vs ASV for Insomnia Randomized Controlled Trial
1 other identifier
interventional
78
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2015
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2015
CompletedFirst Submitted
Initial submission to the registry
February 10, 2015
CompletedFirst Posted
Study publicly available on registry
February 18, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedResults Posted
Study results publicly available
September 9, 2021
CompletedSeptember 9, 2021
May 1, 2021
2.5 years
February 10, 2015
May 24, 2021
August 13, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
Sleep Quality Rating
Baseline and 4 months
Global Morning Rating
4 months
Sleep Onset Latency
4 months
Wake After Sleep Onset (WASO)
4 months
Sleep Efficiency
4 months
Study Arms (2)
Continuous Positive Airway Pressure
ACTIVE COMPARATORContinuous positive airway pressure (CPAP) intervention as active comparator. Provides a fixed pressure for both inspiration and expiration.
Adaptive Servo-Ventilation
EXPERIMENTALAdaptive 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.
Interventions
Device is able to provide both ASV therapy and CPAP therapy modes.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ResMedlead
Study Sites (1)
Maimonides Sleep Arts & Sciences
Albuquerque, New Mexico, 87109, United States
Related Publications (1)
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.
PMID: 31517263DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Barry Krakow
- Organization
- Sleep and Human Health Institute
Study Officials
- PRINCIPAL INVESTIGATOR
Barry Krakow, MD
Sleep & Human Health Institute
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 10, 2015
First Posted
February 18, 2015
Study Start
February 1, 2015
Primary Completion
August 1, 2017
Study Completion
December 1, 2017
Last Updated
September 9, 2021
Results First Posted
September 9, 2021
Record last verified: 2021-05