AzTrials
AzTrials

Obstructive Sleep Apnea (OSA)NCT02549508

Comparison Study Using APAP With and Without SensAwake in Patients With OSA and PTSD

A study testing AutoCPAP with SensAwake On and AutoCPAP with SensAwake Off in people with Obstructive Sleep Apnea (OSA) and Post-Traumatic Stress Disorder (PTSD), run by Fisher and Paykel Healthcare at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this research is to examine the application of AutoCPAP with and without SensAwake in subjects with OSA and Post-Traumatic Stress Disorder (PTSD), and evaluate whether patients achieve better sleep quality and compliance with SensAwake, compared to the same treatment without SensAwake. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
AutoCPAP with SensAwake On and AutoCPAP with SensAwake Off
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
85 participants
Where
1 siteUnited States
Study dates
Oct 2015to May 2018
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

  • Male and female subjects > 18 years Diagnosed with OSA by a practicing sleep physician, within the last six months Diagnosed with post-traumatic stress disorder as diagnosed by a behavioral health professional, and quantified by McChord PTSD checklist All races and ethnicities will be included Naïve to CPAP therapy (has not used CPAP within the last 5 years)

Who cannot join

  • < 18 years of age if mental status is questionable, the patient will be excluded at the discretion of the consenting provider Unable/unwilling to follow the directions necessary for CPAP use Patients contraindicated for CPAP/AutoCPAP, at the discretion of the consenting provider

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Walter Reed National Military Medical Center

    Bethesda, Maryland, 20889

Other trials in United States

About this study

The purpose of this research is to examine the application of AutoCPAP with and without SensAwake in subjects with OSA and Post-Traumatic Stress Disorder (PTSD), and evaluate whether patients achieve better sleep quality and compliance with SensAwake, compared to the same treatment without SensAwake.

Read the detailed description

Conceptually, awareness of pressure occurs only during wakefulness. Thus reducing the pressure during wakefulness may improve therapy comfort and potentially adherence without compromising therapy efficacy. SensAwake™ is a unique pressure relief technology developed by Fisher \& Paykel Healthcare which detects irregularity in the flow signal indicative of the transition from sleep to wake. When the transition from sleep to wake is detected the device promptly reduces the pressure to help facilitate a return to sleep.

It is hypothesised that AutoCPAP with SensAwake will improve patient comfort and compliance in the PTSD and OSA patients who are naïve to CPAP therapy.

The investigators will not be blinded to the study. The participants will be blinded to the study.

Being tested
AutoCPAP with SensAwake On, AutoCPAP with SensAwake Off
Medical subject headings
Sleep Apnea, Obstructive, Stress Disorders, Post-Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AutoCPAP with SensAwake OnDevice

    The comfort feature 'SensAwake' will be turned on

  • AutoCPAP with SensAwake OffDevice

    The comfort feature 'SensAwake' will be turned off

Study groups in NCT02549508
Study groupRoleWhat they receive
AutoCPAP with SensAwake On, then SenAwake OffExperimentalParticipants will start AutoCPAP treatment with SensAwake on for 4 weeks. After 4 weeks, the will cross over to SensAwake off for another 4 weeks.
Receives: Device: AutoCPAP with SensAwake On; Device: AutoCPAP with SensAwake Off
AutoCPAP with SensAwake Off, then SensAwake OnExperimentalParticipants will start AutoCPAP treatment with SensAwake Off for 4 weeks. After 4 weeks, the will cross over to SensAwake On for another 4 weeks.
Receives: Device: AutoCPAP with SensAwake On; Device: AutoCPAP with SensAwake Off

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adherence (Hours on Therapy)

    Hours per night averaged over total time period measured.

    Measured: 4 weeks

Secondary outcomes (2)

  1. Sleep Quality (Epworth Sleepiness Scale (ESS)

    The ESS is a validated questionnaire that assesses an idnviduals likelihood of falling asleep in a variety of given situations (such as having a conversation with someone or stopped a red light while driving.) Each question is given a rating between 0 and 3, with 0 being no chance of falling asleep and 3 being high chance of falling asleep. Answers are then summed together to determine the level of sleepiness an individual is experiencing with a maximum score of 24. The higher the score, the more sleepy the person is. From a clinical perspective an ESS score of 0-10 indicates a normal level sleepiness, a score of 11-14 indicates mild sleepiness, a score of 15-17 indicates moderate sleepiness and a score of 18+ indicates severe sleepiness. Results below are reported as a mean change from baseline in which negative scores indicate reduction in ESS from baseline (less sleepiness). Positive scores indicate increase in ESS from baseline (more sleepiness.)

    Measured: Change from Baseline after 4 weeks

  2. Insomnia Severity Index (ISI)

    ISI; 0-7 = No clinically significant insomnia, 8-14 = Sub threshold insomnia, 15-21 = Clinical insomnia (moderate severity), 22-28 = Clinical insomnia (severe). Results reported in mean change from baseline. Negative scores indicate improvement in ISI, positive scores indicate increase in ISI.

    Measured: Change from Baseline after 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Sep 2015 (estimated)
  2. Study startOct 2015
  3. Primary completionMar 2018
  4. Study completionMay 2018

Resources

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
Crossover
Masking
Single blind
Who is masked
Participant
Enrolment
85 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02549508
Sponsor's protocol ID
CIA 134
Status last verified
Oct 2020
First submitted
9 Sep 2015
Last updated
10 Nov 2020
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Holley A, Shaha D, Costan-Toth C, Slowik J, Robertson BD, Williams SG, Terry S, Golden D, Andrada T, Skeete S, Sheikh K, Butler G, Collen JF. A randomized, placebo-controlled trial using a novel PAP delivery platform to treat patients with OSA and comorbid PTSD. Sleep Breath. 2020 Sep;24(3):1001-1009. doi: 10.1007/s11325-019-01936-x. Epub 2019 Nov 6.

    PubMed 31691105

Questions about this trial

What is this clinical trial studying?

A study testing AutoCPAP with SensAwake On and AutoCPAP with SensAwake Off in people with Obstructive Sleep Apnea (OSA) and Post-Traumatic Stress Disorder (PTSD), run by Fisher and Paykel Healthcare 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 1 inclusion and 1 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 10 Nov 2020. 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 10 Nov 2020). 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?

Adherence (Hours on Therapy) (time frame: 4 weeks). 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 NCT02549508, 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 10 Nov 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in