Online Insomnia Treatment Program

Not Applicable

Recruiting

• Conditions: Sleep Disturbance; Insomnia; Sleep; Sleep Disorder; Sleep Hygiene; Sleep Initiation and Maintenance Disorders
• Interventions: Behavioral: Full Sleep; Behavioral: Path to Better Sleep

• Registration Number: NCT05778812
• Lead Sponsor: Koko Home, Inc.

Brief 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 (650) 721-7576 crismore@stanford.edu

Study Timeline

• Study First Submitted: 2023-03-10
• Study First Submitted QC: 2023-03-10
• Study First Posted: 2023-03-21
• Study Start: 2023-08-11
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-12
• Last Update Posted: 2023-09-14
• Primary Completion: 2024-04
• Study Completion: 2024-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Full Sleep	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.
Path to Better Sleep	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.

Primary Outcome Measures

Name	Time	Method
Insomnia Severity Index	Completion of program (6-8 weeks)	A measure of insomnia symptoms

Secondary Outcome Measures

Name	Time	Method
Sleep efficiency	Completion of program (6-8 weeks)	The proportion of time sleeping while in bed
Total sleep time	Completion of program (6-8 weeks)
Number of awakenings	Completion of program (6-8 weeks)
Sleep onset latency	Completion of program (6-8 weeks)	Minutes to fall asleep
Wakefulness after sleep onset	Completion of program (6-8 weeks)	# minutes awake after falling asleep

Trial Locations

Locations (1)

Stanford Sleep Medicine Center; 🇺🇸 Redwood City, California, United States