InsomniaP2PNCT02365064
CPAP vs ASV for Insomnia
A study testing AirCurve 10 ASV in people with Insomnia and Sleep-Disordered Breathing, run by ResMed at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Insomnia, Sleep-Disordered Breathing
- What is being tested?
- AirCurve 10 ASV
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2015to 1 Dec 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Maimonides Sleep Arts & Sciences
Albuquerque, New Mexico, 87109
About this study
Official title: 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.
Read the 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
- Being tested
- AirCurve 10 ASV
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AirCurve 10 ASVDevice
Also called VPAP Adapt, AutoSet CS2
Device is able to provide both ASV therapy and CPAP therapy modes.
| Study group | Role | What they receive |
|---|---|---|
| Continuous Positive Airway Pressure | Active comparator | Continuous positive airway pressure (CPAP) intervention as active comparator. Provides a fixed pressure for both inspiration and expiration. Receives: Device: AirCurve 10 ASV |
| Adaptive Servo-Ventilation | Experimental | 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. Receives: Device: AirCurve 10 ASV |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 4 months
Secondary outcomes (5)
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
Measured: 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
Measured: 4 months
Sleep Onset Latency
Change in from baseline to 4 months in sleep onset time (minutes)
Measured: 4 months
Wake After Sleep Onset (WASO)
Change from baseline to 4 months for WASO in minutes
Measured: 4 months
Sleep Efficiency
Change from baseline to 4 months in sleep efficiency (total sleep time/time in bed)
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2015 (estimated)
- Study startFeb 2015
- Primary completionAug 2017
- Study completion1 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InsomniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- ResMed
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Barry Krakow, MD, Principal investigator, Sleep & Human Health Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02365064
- Sponsor's protocol ID
- 682031-1_MA20150206
- Acronym
- P2P
- Status last verified
- May 2021
- First submitted
- 10 Feb 2015
- Last updated
- 9 Sep 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
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.
PubMed 31517263
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PAP to PAP: CPAP vs ASV for Insomnia Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02365064
- Acronym / sponsor ID
- P2P / 682031-1_MA20150206
- Conditions
- Insomnia, Sleep-Disordered Breathing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- ResMedIndustry (pharma, biotech, devices)
- Study start
- Feb 2015 (actual)
- Primary completion
- Aug 2017 (actual)
- Study completion
- 1 Dec 2017 (actual)
- First posted
- 18 Feb 2015 (estimated)
- Results
- Posted 9 Sep 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuous Positive Airway Pressure | Active comparator | Device: AirCurve 10 ASVContinuous positive airway pressure (CPAP) intervention as active comparator. Provides a fixed pressure for both inspiration and expiration. |
| Adaptive Servo-Ventilation | Experimental | Device: AirCurve 10 ASVAdaptive 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AirCurve 10 ASVAlso: VPAP Adapt, AutoSet CS2Device is able to provide both ASV therapy and CPAP therapy modes. | Device | Adaptive Servo-Ventilation, Continuous Positive Airway Pressure |
Primary outcome
Insomnia Severity Index
Time frame: Baseline and 4 months
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.
5 secondary outcomes
Sleep Quality Rating
Time frame: Baseline and 4 months
Global Morning Rating
Time frame: 4 months
Sleep Onset Latency
Time frame: 4 months
Wake After Sleep Onset (WASO)
Time frame: 4 months
Sleep Efficiency
Time frame: 4 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31517263Krakow 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barry Krakow, MD principal investigator
Sleep & Human Health Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AirCurve 10 ASV in people with Insomnia and Sleep-Disordered Breathing, run by ResMed at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Sep 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insomnia Severity Index (time frame: Baseline and 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02365064, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2021.