Naturalistic Monitoring and Treatment of Chronic Insomnia
- Conditions
- Chronic Insomnia
- Interventions
- Device: SleepScore Max coaching featureBehavioral: Online CBTi
- Registration Number
- NCT04013321
- Lead Sponsor
- Washington State University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 112
- 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
- Non-English speaking
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Test intervention group SleepScore Max coaching feature Chronic insomniacs will track their sleep with the SleepScore Max device and will receive feedback and coaching from the Smartphone app associated with the device. Active control Online CBTi Chronic insomniacs in the active control group will be tracking their sleep with the device, without feedback or coaching. But they will also undergo online cognitive behavioral therapy for insomnia (CBTi).
- Primary Outcome Measures
Name Time Method Sleep Duration 10 weeks Quantify sleep duration using Actigraphy in:
* Passive control insomniacs vs healthy controls
* Insomnia groups
- Secondary Outcome Measures
Name Time Method Sleep latency 10 weeks Quantify sleep latency using actigraphy in:
* Passive control insomniacs vs healthy controls
* Insomnia groupsIntermittent wakefulness 10 weeks Quantify intermittent wakefulness using actigraphy in:
* Passive control insomniacs vs healthy controls
* Insomnia groups
Trial Locations
- Locations (1)
Sleep and Performance Research Center
🇺🇸Spokane, Washington, United States