NCT02392000

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2015

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

February 12, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 18, 2015

Completed
7 months until next milestone

Study Start

First participant enrolled

October 20, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 16, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 16, 2016

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

March 9, 2018

Completed
Last Updated

April 20, 2018

Status Verified

March 1, 2018

Enrollment Period

1.1 years

First QC Date

February 12, 2015

Results QC Date

February 5, 2018

Last Update Submit

March 19, 2018

Conditions

Chronic Insomnia

Keywords

chronic insomniaVeterans Health

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    Week 0 (Pre-Intervention) and Week 6 (Post-Intervention)

Secondary Outcomes (3)

  • Insomnia Severity Index Score

    Week 0 (Pre-Intervention) and Week 4 (Mid-Intervention) and Week 6 (Post-Intervention)

  • Pittsburgh Sleep Quality Index (PSQI) Total Score

    Week 0 (Pre-Intervention) and Week 4 (Mid-Intervention) and Week 6 (Post-Intervention)

  • Functional Outcomes of Sleep Score

    Week 0 (Pre-Intervention) and Week 4 (Mid-Intervention) and Week 6 (Post-Intervention)

Study Arms (1)

WatchPAT and CBT-i Coach mobile app

EXPERIMENTAL

Individuals use the WatchPAT sleep monitor and the CBT-i Coach app to self-manage insomnia

Device: WatchPAT sleep monitorBehavioral: CBT-i Coach mobile app

Interventions

WatchPAT sleep monitorDEVICE

Self-management of insomnia using a mobile sleep device

WatchPAT and CBT-i Coach mobile app
CBT-i Coach mobile appBEHAVIORAL

Self-management of insomnia using a mobile app based on Cognitive Behavioral Therapy for Insomnia

WatchPAT and CBT-i Coach mobile app

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • periodic leg movements,
  • or circadian rhythm disorder (delayed or advanced sleep phase).
  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA

Bedford, Massachusetts, 01730, United States

Location

Related Publications (2)

  • 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.

    PMID: 36530383DERIVED

  • Reilly 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.

    PMID: 31342904DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Results Point of Contact

Title
Karen S. Quigley
Organization
Edith Nourse Rogers Memorial VA Hospital
karen.quigley@va.gov
781-687-2273

Study Officials

  • Karen S. Quigley, PhD

    Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 12, 2015

First Posted

March 18, 2015

Study Start

October 20, 2015

Primary Completion

November 16, 2016

Study Completion

November 16, 2016

Last Updated

April 20, 2018

Results First Posted

March 9, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)