N/A N=38 Treatment

Mobile Sleep Intervention for OEF, OIF and OND Veterans

Chronic Insomnia

Bottom Line

View on ClinicalTrials.gov: NCT02392000 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2018

Primary outcome: Primary: Number of Participants Using WatchPAT — 11; 11 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: WatchPAT sleep monitor (Device); CBT-i Coach mobile app (Behavioral)
Age: Adult, Older Adult · 21+ yrs
Sex: All
Sponsor: VA Office of Research and Development
Primary completion: Nov 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants Using WatchPAT	11; 11	—
PRIMARY Number of Participants Using CBT-I Coach	11; 9	—
SECONDARY Insomnia Severity Index Score	16.6; 12.4; 12.8	—
SECONDARY Pittsburgh Sleep Quality Index (PSQI) Total Score	12.8; 10.4; 10.7	—
SECONDARY Functional Outcomes of Sleep Score	13.9; 15.2; 15.4	—

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.

Eligibility Criteria

Inclusion Criteria

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).

Exclusion Criteria

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.
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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02392000). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.