Chronic InsomniaNCT02392000
Mobile Sleep Intervention for OEF, OIF and OND Veterans
A study testing WatchPAT sleep monitor and CBT-i Coach mobile app in people with Chronic Insomnia, run by VA Office of Research and Development at 1 site in United States.
Trial summary
Many Veterans of the recent wars in Iraq and Afghanistan struggle with chronic insomnia (trouble falling or staying asleep). Most current interventions for insomnia are time-consuming, making it difficult for this younger, working group of Veterans to use and benefit from these interventions. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Chronic Insomnia
- What is being tested?
- WatchPAT sleep monitor and CBT-i Coach mobile app
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Oct 2015to 16 Nov 2016
- 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 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must have served in the most recent wars in Iraq or Afghanistan (OIF, OEF or OND),
- be age 21-65,
- report current insomnia as defined by an Insomnia Index Severity 40 score > 10 5,79,
- and report insomnia duration of at least 1 month and impaired daytime functioning (as measured by endorsing Much or Very Much on ISI Item 7 about how much sleep problems interfere with daily functioning).
- In addition, eligible individuals must be willing to use a device provided by the study team (an iPod touch).
Who cannot join
- Exclusions will include self-reported (or in-study determined) sleep apnea that is more than mild,
- periodic leg movements,
- or circadian rhythm disorder (delayed or advanced sleep phase).
- Exclusions for WatchPAT use include use of alpha blockers or short-acting nitrates,
- permanent pacemaker, or
- sustained non-sinus cardiac arrhythmias. Sleep apnea will be assessed from the WatchPAT on the first night of objective sleep testing and participants excluded from further participation if apnea is documented.
Show all 11Show fewer
- Other exclusions include moderate to severe cognitive impairment defined by scores on the Telephone Mini Mental State Exam,
- inability to speak and read English,
- or malformation of the fingers that would preclude use of the WatchPAT device.
- In addition, individuals meeting criteria for current active psychosis, mania, suicidal ideation with plan and intent, or excessive alcohol use as determined using the AUDIT-C will be excluded from participation.
- Those with greater than mild sleep apnea as determined based on a WatchPAT-based Apnea-Hypopnea Index [AHI] > 15/hour of sleep, will be withdrawn from the study and referred for sleep apnea treatment.
Trial locations and contacts
1 site in 1 country.
United States1 site
Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA
Bedford, Massachusetts, 01730
About this study
Official title: Mobile Sleep and Pain Intervention for OEF, OIF and OND Veterans
Many Veterans of the recent wars in Iraq and Afghanistan struggle with chronic insomnia (trouble falling or staying asleep). Most current interventions for insomnia are time-consuming, making it difficult for this younger, working group of Veterans to use and benefit from these interventions. The investigators will assess whether Veterans find it helpful to use two health information technology tools, one for measuring participant sleep (the WatchPAT) and one for managing participant sleep (the CBTI Coach). The WatchPAT will measure physiological sleep in the Veteran participant's home. The CBTI Coach is a mobile health application used on the Veteran's mobile phone or tablet to teach skills that can reduce insomnia. The investigators will combine use of the WatchPAT with the CBTI Coach so Veterans can self-manage insomnia at home. Participants will record their physiological sleep and self-report on their sleep at home during a 6 week self-management program. The investigators will measure if Veterans find the tools helpful and easy to use, and which Veterans find the tools most helpful.
Read the detailed description
Sleep disturbance in the form of chronic insomnia (difficulty in falling or staying asleep) is a major health care problem for Operation Enduring Freedom (OEF), Operation Iraqi Freedom (OIF), and Operation New Dawn (OND) Veterans. Chronic insomnia is often co-morbid with mental and behavioral health issues such as posttraumatic stress disorder (PTSD) and mild traumatic brain injury (mTBI), which are common in these Veterans. Current behavioral interventions like cognitive behavioral therapy for insomnia (CBTI) that are used to treat chronic insomnia are effective, but time-consuming. As a result, this largely younger, working cohort of Veterans does not use and benefit from these interventions as much as they could. The investigators will assess the usability and feasibility of two health information technology (HIT) tools for measuring objective and subjective sleep, and for self-managing chronic insomnia. An existing mobile sleep monitoring device used by some VA sleep clinics, the WatchPAT, will be used to measure objective sleep parameters in the Veteran's home. A benefit of this tool is that it can detect probable sleep apnea, which will permit referral of these Veterans for sleep apnea treatment instead of insomnia self-management. An existing VA mobile health application (or app), the CBTI Coach, can be used on a mobile device to teach skills to reduce insomnia based on the elements of manualized CBTI. The goal is to combine the WatchPAT and the CBTI Coach along with self-management guidance to help Veterans with chronic insomnia learn how to improve their sleep. As part of a 6-week pre-post intervention pilot usability and feasibility trial, patients will record their objective and subjective sleep at home at the beginning of the 6-week self-management trial and again at the end. Subjective sleep reports in the form of sleep diaries will be measured throughout the program as part of using the CBTI Coach app. The objective and subjective sleep reports will be combined and accessible from the mobile device and can be used to help guide sleep self-management by the participant. Self-management will be aided by self-management worksheets and features of the CBTI Coach App. Usability of the two HIT tools will be assessed within the conceptual framework of an Integrated Technology Acceptance Model via survey items about each of the HIT tools. Feasibility will be assessed using measures of the number of times that elements of the CBTI Coach were accessed during the 6-week program, and from a semi-structured qualitative interview conducted at the end of the program. In the interview, the investigators will obtain information about the barriers to and facilitators of use of the WatchPAT and CBTI Coach. If there is high use of these tools for insomnia self-management, then the pilot study will have provided important incremental value to the new VA CBTI Coach app. The investigators also will collect data about the user factors that impact use of the tools (e.g., depression, mild traumatic brain injury, age), and thereby either be able to target the tools toward those most likely to use them, or suggest further developments to increase use by potential users. The pilot sample will provide preliminary data on sleep outcomes. The proposed work is responsive to multiple priority areas for HSR\&D including Healthcare Informatics, Healthcare Access, Mental and Behavioral Health, and Post-deployment Health. By partnering with the VA Office of Connected Health (Web and Mobile Solutions), the VA's eHealth QUERI, and the developers of the VA CBTI Coach App, the investigators will ensure that these findings are maximally useful for future versions of the CBTI Coach app. The investigators also will be able to determine the usefulness of an integrated mobile sleep assessment and self-management program that can be used by Veterans anywhere.
- Conditions
- Chronic Insomnia
- Being tested
- WatchPAT sleep monitor, CBT-i Coach mobile app
- Keywords
- chronic insomnia, Veterans Health
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WatchPAT sleep monitorDevice
Self-management of insomnia using a mobile sleep device
CBT-i Coach mobile appBehavioural
Self-management of insomnia using a mobile app based on Cognitive Behavioral Therapy for Insomnia
| Study group | Role | What they receive |
|---|---|---|
| WatchPAT and CBT-i Coach mobile app | Experimental | Individuals use the WatchPAT sleep monitor and the CBT-i Coach app to self-manage insomnia Receives: Device: WatchPAT sleep monitor; Behavioral: CBT-i Coach mobile app |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Using WatchPAT
Use of WatchPAT on 3 nights. In Week 0 it is the number of participants who used the WatchPAT that Week (and participants had two possible nights during that week that they could use the WatchPAT). In Week 6 it is the number of participants who used the WatchPAT that Week (and participants had one night that they could use the WatchPAT). We measured participant adherence using a count of the number of participants who used the WatchPAT at Week 0, and the number of participants using the WatchPAT at Week 6.
Measured: Week 0 (Pre-Intervention) and Week 6 (Post-Intervention)
Number of Participants Using CBT-I Coach
CBT = Cognitive Behavioral Therapy. Use of CBT-I Coach sleep diaries in Week 0 and Week 6. We measured participant adherence by a count of the number of participants who used the CBT-I Coach at Week 0 (by our definition of use), and the number of participants using the CBT-I Coach at Week 6. Because of the small number of completers and because this is a feasibility study, we provide only descriptive data.
Measured: Week 0 (Pre-Intervention) and Week 6 (Post-Intervention)
Secondary outcomes (3)
Insomnia Severity Index Score
Validated self-report measure of Insomnia Symptom Severity (ISI). The minimum ISI scale score is 0, the maximum scale score is 28, and higher scores indicate worse insomnia. Because of the small number of completers and because this is a feasibility study, we provide only descriptive data in the form of means (and standard deviation).
Measured: Week 0 (Pre-Intervention) and Week 4 (Mid-Intervention) and Week 6 (Post-Intervention)
Pittsburgh Sleep Quality Index (PSQI) Total Score
Validated self-report measure of self-reported sleep quality. The minimum PSQI Total scale score is 0, the maximum scale score is 21 and higher scale scores indicate worse subjective sleep quality. Because of the small number of completers and because this is a feasibility study, we provide only descriptive data in the form of means (and standard deviation).
Measured: Week 0 (Pre-Intervention) and Week 4 (Mid-Intervention) and Week 6 (Post-Intervention)
Functional Outcomes of Sleep Score
Validated self-report short-form (10 item) measure of Functional Outcomes of Sleep-10 (FOSQ-10). The minimum FOSQ score is 5, the maximum score is 20, and higher scores indicate better functioning. Because of the small number of completers and because this is a feasibility study, we provide only descriptive data in the form of means (and standard deviation).
Measured: Week 0 (Pre-Intervention) and Week 4 (Mid-Intervention) and Week 6 (Post-Intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2015 (estimated)
- Study start20 Oct 2015
- Primary completion16 Nov 2016
- Study completion16 Nov 2016
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 (2)Papers the sponsor has linked to this study.
- Other trials for Chronic InsomniaStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- University of Rochester, Northeastern University
- Responsible party
- Sponsor
- Investigators
- Karen S. Quigley, PhD, Principal investigator, Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02392000
- Sponsor's protocol ID
- PPO 14-144
- Status last verified
- Mar 2018
- First submitted
- 12 Feb 2015
- Last updated
- 20 Apr 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Kaitz J, Robinson SA, Petrakis BA, Reilly ED, Chamberlin ES, Wiener RS, Quigley KS. Veteran Acceptance of Sleep Health Information Technology: a Mixed-Method Study. J Technol Behav Sci. 2023;8(1):57-68. doi: 10.1007/s41347-022-00287-x. Epub 2022 Dec 13.
PubMed 36530383Reilly ED, Robinson SA, Petrakis BA, Kuhn E, Pigeon WR, Wiener RS, McInnes DK, Quigley KS. Mobile App Use for Insomnia Self-Management: Pilot Findings on Sleep Outcomes in Veterans. Interact J Med Res. 2019 Jul 24;8(3):e12408. doi: 10.2196/12408.
PubMed 31342904
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobile Sleep and Pain Intervention for OEF, OIF and OND Veterans
- ClinicalTrials.gov ID
- NCT02392000
- Acronym / sponsor ID
- PPO 14-144
- Conditions
- Chronic Insomnia
- Keywords
- chronic insomnia, Veterans Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- University of Rochester, Northeastern University
- Study start
- 20 Oct 2015 (actual)
- Primary completion
- 16 Nov 2016 (actual)
- Study completion
- 16 Nov 2016 (actual)
- First posted
- 18 Mar 2015 (estimated)
- Results
- Posted 9 Mar 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Many Veterans of the recent wars in Iraq and Afghanistan struggle with chronic insomnia (trouble falling or staying asleep). Most current interventions for insomnia are time-consuming, making it difficult for this younger, working group of Veterans to use and benefit from these interventions. The investigators will assess whether Veterans find it helpful to use two health information technology tools, one for measuring participant sleep (the WatchPAT) and one for managing participant sleep (the CBTI Coach). The WatchPAT will measure physiological sleep in the Veteran participant's home. The CBTI Coach is a mobile health application used on the Veteran's mobile phone or tablet to teach skills that can reduce insomnia. The investigators will combine use of the WatchPAT with the CBTI Coach so Veterans can self-manage insomnia at home. Participants will record their physiological sleep and self-report on their sleep at home during a 6 week self-management program. The investigators will measure if Veterans find the tools helpful and easy to use, and which Veterans find the tools most helpful.
Detailed description
Sleep disturbance in the form of chronic insomnia (difficulty in falling or staying asleep) is a major health care problem for Operation Enduring Freedom (OEF), Operation Iraqi Freedom (OIF), and Operation New Dawn (OND) Veterans. Chronic insomnia is often co-morbid with mental and behavioral health issues such as posttraumatic stress disorder (PTSD) and mild traumatic brain injury (mTBI), which are common in these Veterans. Current behavioral interventions like cognitive behavioral therapy for insomnia (CBTI) that are used to treat chronic insomnia are effective, but time-consuming. As a result, this largely younger, working cohort of Veterans does not use and benefit from these interventions as much as they could. The investigators will assess the usability and feasibility of two health information technology (HIT) tools for measuring objective and subjective sleep, and for self-managing chronic insomnia. An existing mobile sleep monitoring device used by some VA sleep clinics, the WatchPAT, will be used to measure objective sleep parameters in the Veteran's home. A benefit of this tool is that it can detect probable sleep apnea, which will permit referral of these Veterans for sleep apnea treatment instead of insomnia self-management. An existing VA mobile health application (or app), the CBTI Coach, can be used on a mobile device to teach skills to reduce insomnia based on the elements of manualized CBTI. The goal is to combine the WatchPAT and the CBTI Coach along with self-management guidance to help Veterans with chronic insomnia learn how to improve their sleep. As part of a 6-week pre-post intervention pilot usability and feasibility trial, patients will record their objective and subjective sleep at home at the beginning of the 6-week self-management trial and again at the end. Subjective sleep reports in the form of sleep diaries will be measured throughout the program as part of using the CBTI Coach app. The objective and subjective sleep reports will be combined and accessible from the mobile device and can be used to help guide sleep self-management by the participant. Self-management will be aided by self-management worksheets and features of the CBTI Coach App. Usability of the two HIT tools will be assessed within the conceptual framework of an Integrated Technology Acceptance Model via survey items about each of the HIT tools. Feasibility will be assessed using measures of the number of times that elements of the CBTI Coach were accessed during the 6-week program, and from a semi-structured qualitative interview conducted at the end of the program. In the interview, the investigators will obtain information about the barriers to and facilitators of use of the WatchPAT and CBTI Coach. If there is high use of these tools for insomnia self-management, then the pilot study will have provided important incremental value to the new VA CBTI Coach app. The investigators also will collect data about the user factors that impact use of the tools (e.g., depression, mild traumatic brain injury, age), and thereby either be able to target the tools toward those most likely to use them, or suggest further developments to increase use by potential users. The pilot sample will provide preliminary data on sleep outcomes. The proposed work is responsive to multiple priority areas for HSR\&D including Healthcare Informatics, Healthcare Access, Mental and Behavioral Health, and Post-deployment Health. By partnering with the VA Office of Connected Health (Web and Mobile Solutions), the VA's eHealth QUERI, and the developers of the VA CBTI Coach App, the investigators will ensure that these findings are maximally useful for future versions of the CBTI Coach app. The investigators also will be able to determine the usefulness of an integrated mobile sleep assessment and self-management program that can be used by Veterans anywhere.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| WatchPAT and CBT-i Coach mobile app | Experimental | Device: WatchPAT sleep monitor, Behavioral: CBT-i Coach mobile appIndividuals use the WatchPAT sleep monitor and the CBT-i Coach app to self-manage insomnia |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participants must have served in the most recent wars in Iraq or Afghanistan (OIF, OEF or OND),
- be age 21-65,
- report current insomnia as defined by an Insomnia Index Severity 40 score > 10 5,79,
- and report insomnia duration of at least 1 month and impaired daytime functioning (as measured by endorsing Much or Very Much on ISI Item 7 about how much sleep problems interfere with daily functioning).
- In addition, eligible individuals must be willing to use a device provided by the study team (an iPod touch).
Key exclusion criteria (11 listed)
- Exclusions will include self-reported (or in-study determined) sleep apnea that is more than mild,
- periodic leg movements,
- or circadian rhythm disorder (delayed or advanced sleep phase).
- Exclusions for WatchPAT use include use of alpha blockers or short-acting nitrates,
- permanent pacemaker, or
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 |
|---|---|---|
| WatchPAT sleep monitorSelf-management of insomnia using a mobile sleep device | Device | WatchPAT and CBT-i Coach mobile app |
| CBT-i Coach mobile appSelf-management of insomnia using a mobile app based on Cognitive Behavioral Therapy for Insomnia | Behavioural | WatchPAT and CBT-i Coach mobile app |
Primary outcome
Number of Participants Using WatchPAT
Time frame: Week 0 (Pre-Intervention) and Week 6 (Post-Intervention)
Use of WatchPAT on 3 nights. In Week 0 it is the number of participants who used the WatchPAT that Week (and participants had two possible nights during that week that they could use the WatchPAT). In Week 6 it is the number of participants who used the WatchPAT that Week (and participants had one night that they could use the WatchPAT). We measured participant adherence using a count of the number of participants who used the WatchPAT at Week 0, and the number of participants using the WatchPAT at Week 6.
Number of Participants Using CBT-I Coach
Time frame: Week 0 (Pre-Intervention) and Week 6 (Post-Intervention)
CBT = Cognitive Behavioral Therapy. Use of CBT-I Coach sleep diaries in Week 0 and Week 6. We measured participant adherence by a count of the number of participants who used the CBT-I Coach at Week 0 (by our definition of use), and the number of participants using the CBT-I Coach at Week 6. Because of the small number of completers and because this is a feasibility study, we provide only descriptive data.
3 secondary outcomes
Insomnia Severity Index Score
Time frame: Week 0 (Pre-Intervention) and Week 4 (Mid-Intervention) and Week 6 (Post-Intervention)
Pittsburgh Sleep Quality Index (PSQI) Total Score
Time frame: Week 0 (Pre-Intervention) and Week 4 (Mid-Intervention) and Week 6 (Post-Intervention)
Functional Outcomes of Sleep Score
Time frame: Week 0 (Pre-Intervention) and Week 4 (Mid-Intervention) and Week 6 (Post-Intervention)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36530383Kaitz J, Robinson SA, Petrakis BA, Reilly ED, Chamberlin ES, Wiener RS, Quigley KS. Veteran Acceptance of Sleep Health Information Technology: a Mixed-Method Study. J Technol Behav Sci. 2023;8(1):57-68. doi: 10.1007/s41347-022-00287-x. Epub 2022 Dec 13.
- Derived from this study: PubMed 31342904Reilly ED, Robinson SA, Petrakis BA, Kuhn E, Pigeon WR, Wiener RS, McInnes DK, Quigley KS. Mobile App Use for Insomnia Self-Management: Pilot Findings on Sleep Outcomes in Veterans. Interact J Med Res. 2019 Jul 24;8(3):e12408. doi: 10.2196/12408.
- Individual participant dataSharing planned: No
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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.
Karen S. Quigley, PhD principal investigator
Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WatchPAT sleep monitor and CBT-i Coach mobile app in people with Chronic Insomnia, run by VA Office of Research and Development 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 5 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 20 Apr 2018. 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 Mar 2018). 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?
Number of Participants Using WatchPAT (time frame: Week 0 (Pre-Intervention) and Week 6 (Post-Intervention)). The study lists 2 primary outcomes in all. 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 NCT02392000, which also lists 2 linked publications.
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 20 Apr 2018.