An interventional study of Full Sleep and Path to Better Sleep in Insomnia, Sleep and Sleep Disturbance, sponsored by Koko Home, Inc.. Recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-14.
Sponsored by Koko Home, Inc. · Not applicable, Interventional, and Treatment
The purpose of this study is to investigate improvements in sleep by comparing two 6-week digital programs, either online or app-based, that deliver Cognitive Behavioral Therapy for Insomnia (CBT-I), the "gold standard" treatment for insomnia, with or without a bedside device to help track sleep.
Time needed from participant: 15 minutes per day to complete an app-based or online sleep diary and review information in an app-based or online CBT-I program.
To qualify, you must:
Be 18+ years old Have a diagnosis of insomnia or suspected insomnia Have access to the internet and an iphone, Android or other smart phone device
Coordinator Contact:
Cris Moreno (650) 721-7576 crismore@stanford.edu
1,856 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 594 are open to participants now.
This study's planned enrollment of 200 is above the median of 73 across 1,631 interventional studies indexed under Sleep Initiation and Maintenance Disorders.
Browse Sleep Initiation and Maintenance Disorders studies →This is the only study on the registry with Koko Home, Inc. as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants should be aware that should they receive a device, its sound and light alerts could be disruptive to partners or others (e.g., children) that sleep in the same room.
With Full Sleep, the app provides daily lessons about sleep and skills that can help with sleep. In the app, participants also record information about each night's sleep in their sleep log. Every seven nights, they also complete the Sleep Needs Questionnaire. At the beginning, middle, and end of the study, they additionally complete the Insomnia Severity Inventory in the app. At the end of every week, a sleep schedule and weekly summary are calculated via automated formulas. The app also contains access to messaging a coach. The intent of coach access is for participants to ask questions about their daily lessons and application of the skills and to feel supported and accountable. The REST (Radar Enabled Sensing Technology) device in the Full Sleep program uses radar to passively track sleep patterns and nighttime awakenings. It also offers white noise options and audio guidance for relaxation techniques and stimulus control.
Behavioral: Full Sleep
Path to Better Sleep is a self-management tool for insomnia. It is available as a web-based program at https://www.veterantraining.va.gov/apps/insomnia/index.html#dashboard. Path to Better Sleep is intended to be completed over six weeks, and includes weekly educational lessons about sleep which include videos, visual depictions, and interactive activities, in addition to sleep check-ins (e.g., knowledge checks, self reflections about sleep). It also includes sleep logging. Participants in this condition will be asked to share their sleep log weekly via email, as Stanford and Koko Labs do not receive access to the data.
Behavioral: Path to Better Sleep
Daily lessons about sleep and skills that can help with sleep. Participants also record information about each night's sleep in their sleep log. Every seven nights, they also complete the Sleep Needs Questionnaire. At the beginning, middle, and end of the study, they complete the Insomnia Severity Inventory in the app. At the end of every week, a sleep schedule and weekly summary are calculated via automated formulas. The app also contains access to messaging a coach, for participants to ask questions about their daily lessons and application of the skills and to feel supported and accountable. The REST device in the Full Sleep program uses radar to passively track sleep patterns and nighttime awakenings. It also offers white noise options and audio guidance for relaxation techniques and stimulus control.
Path to Better Sleep is a self-management tool for insomnia. It is available as a web-based program at https://www.veterantraining.va.gov/apps/insomnia/index.html#dashboard. Path to Better Sleep is intended to be completed over six weeks, and includes weekly educational lessons about sleep which include videos, visual depictions, and interactive activities, in addition to sleep check-ins (e.g., knowledge checks, self reflections about sleep). It also includes sleep logging. Participants in this condition will be asked to share their sleep log weekly via email, as Stanford and Koko Labs do not receive access to the data.
Insomnia Severity Index
A measure of insomnia symptoms
Time frame: Completion of program (6-8 weeks)
Sleep efficiency
The proportion of time sleeping while in bed
Time frame: Completion of program (6-8 weeks)
Wakefulness after sleep onset
# minutes awake after falling asleep
Time frame: Completion of program (6-8 weeks)
Number of awakenings
Time frame: Completion of program (6-8 weeks)
Sleep onset latency
Minutes to fall asleep
Time frame: Completion of program (6-8 weeks)
Total sleep time
Time frame: Completion of program (6-8 weeks)
Plan to share: No
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Sleep Initiation and Maintenance Disorders→