NCT04013321

Naturalistic Monitoring and Treatment of Chronic Insomnia

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 112 (actual)
• Sponsor: Washington State University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Chronic Insomnia

Interventions

Type	Name	Description
DEVICE	SleepScore Max coaching feature	The SleepScore max is a non-contact sleep tracking device. The app has an integrated feedback coaching feature to improve sleep.
BEHAVIORAL	Online 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.

Timeline

• Start date: 2020-01-23
• Primary completion: 2021-08-10
• Completion: 2021-10-10
• First posted: 2019-07-09
• Last updated: 2023-04-26

Locations

1 site across 1 country: United States