Chronic Insomnia
Conditions
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.
Interventions
DEVICESleepScore Max coaching feature
The SleepScore max is a non-contact sleep tracking device. The app has an integrated feedback coaching feature to improve sleep.
BEHAVIORALOnline CBTi
Online Cognitive Behavioral Therapy for insomnia 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.
Sponsors
National Institutes of Health (NIH)
National Center for Advancing Translational Sciences (NCATS)
Washington State University
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sleep Duration | 10 weeks | Quantify sleep duration using SleepScore Max in: * Passive control insomniacs vs healthy controls * Insomnia groups |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sleep latency | 10 weeks | Quantify sleep latency using SleepScore Max in: * Passive control insomniacs vs healthy controls * Insomnia groups |
| Intermittent wakefulness | 10 weeks | Quantify intermittent wakefulness using SleepScore Max in: * Passive control insomniacs vs healthy controls * Insomnia groups |
Countries
United States
Outcome results
None listed