Clinical trial NCT04013321: Naturalistic Monitoring and Treatment of Chronic Insomnia
Official title: Naturalistic Monitoring and Treatment of Chronic Insomnia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Insomnia
Lead sponsor: Washington State University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Center for Advancing Translational Sciences (NCATS)
First posted: 2019-07-09
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: 90 individuals with chronic insomniacs and 30 healthy normal sleepers will have their sleep monitored by the SleepScore Max for 10 weeks. Individuals with chronic insomnia will be randomized into one of three groups (30 subjects in each): a test intervention group, a passive control group, and an active control group. The purpose of the study is to examine if the SleepScore max provides a accurate measurement of sleep relative to a validated, wrist-worn sleep monitor and if a integrated coaching feature within the SleepScore Max facilitates improvement in sleep relative to other gold standard treatment methods.

Detailed description: 90 chronic insomniacs, carefully screened using the criteria of Chronic Insomnia Disorder according to the International Classification of Sleep Disorders 3 (ICSD-3), will be studied. Additionally, 30 healthy normal sleepers will be included as controls. The duration of study participation will be 10 weeks. All subjects will wear an actigraph during week 1 to record baseline sleep patterns, followed by 8 weeks of recording with the SleepScore Max. During week 10, the subjects will wear the actigraph again to measure post intervention sleep. The healthy subjects will be used as a control to test if the SleepScore Max can track sleep well as compared to actigraphy. The subjects with chronic insomnia will be randomized into one of three groups (30 subjects in each). One of these groups is the test intervention group, in which subjects will track their sleep with the SleepScore Max device and will receive feedback and coaching from the Smartphone app associated with the device. The other two groups will serve as passive and active controls. The passive control group will track their sleep using the SleepScore Max device, but without any feedback or coaching. The active control group will also be tracking their sleep with the device, without feedback or coaching, but they will also undergo online CBTi which is a user guided program to track sleep, receive sleep coaching, and initiate behavioral techniques such as tailored sleep scheduling and sleep hygiene to help improve sleep.

Eligibility criteria: Inclusion Criteria:

* Age 18-65
* Physically and psychologically healthy (except for chronic insomnia for the insomnia participants) as assessed by questionnaires and history
* No sleep disorders other than chronic insomnia (for insomnia participants only) as assessed by questionnaires and history
* Has daily access to an iPhone

Exclusion Criteria:

* Non-English speaking

Primary outcomes:
measure: Sleep Duration
timeFrame: 10 weeks
measure: Sleep Duration
timeFrame: 10 weeks
Secondary outcomes:
measure: Sleep latency
timeFrame: 10 weeks
measure: Sleep latency
timeFrame: 10 weeks
measure: Intermittent wakefulness
timeFrame: 10 weeks
measure: Intermittent wakefulness
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Spokane
country: United States
facility: Sleep and Performance Research Center
state: Washington
Study officials:
References: