Online Insomnia Treatment Program

Not Applicable

Recruiting

• Conditions: Sleep Disturbance; Insomnia; Sleep; Sleep Disorder; Sleep Hygiene; Sleep Initiation and Maintenance Disorders

• 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

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
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
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)

Trial Locations

Locations (1)

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