NCT05778812

Online Insomnia Treatment Program

A Study on Online Insomnia Treatment Programs

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Koko Home, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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 [phone] [e-mail]

Conditions

• Insomnia
• Sleep
• Sleep Disturbance
• Sleep Disorder
• Sleep Hygiene
• Sleep Initiation and Maintenance Disorders

Interventions

Type	Name	Description
BEHAVIORAL	Full 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.
BEHAVIORAL	Path to Better 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.

Timeline

• Start date: 2023-08-11
• Primary completion: 2024-04-01
• Completion: 2024-04-01
• First posted: 2023-03-21
• Last updated: 2023-09-14

Locations

1 site across 1 country: United States