Trials Today

Online Insomnia Treatment Program

Purpose

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.

Conditions

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

Eligibility

Eligible Ages: Over 18 Years
Eligible Sex: All
Accepts Healthy Volunteers: Yes

Inclusion Criteria

insomnia diagnosis or measure-confirmed moderate to severity insomnia (Insomnia Severity Index = 15-28) - access to an iPhone with iOS 11+ or Samsung, Google, HTC, LG, OnePlus, or Motorola phone with Android 10+ - 18 years of age or older - available 15 mins per day to participate

Exclusion Criteria

Restless Legs Syndrome - narcolepsy - sleep apnea - sleep walking - bipolar disorder - seizures disorder - substance abuse - frailty/risk of falling - severe memory problems - shift work - change in antidepressant medication within past 2 months - serious mental/physical health problem - other ongoing psychological treatment w - sleeping with pets. 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.

Study Design

Phase: N/A
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking: Single (Outcomes Assessor)

Arm Groups

Arm	Description	Assigned Intervention
Experimental Full Sleep	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 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.
Active Comparator 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.	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.

Recruiting Locations

Stanford Sleep Medicine Center
Redwood City 5386834, California 5332921 94063

Contact:
Cris Moreno
650-721-7576
crismore@stanford.edu

More Details

NCT ID: NCT05778812
Status: Unknown status
Sponsor: Koko Home, Inc.

Study Contact

Cris Moreno
650-721-7576
crismore@stanford.edu

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 (650) 721-7576 crismore@stanford.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.