Online Insomnia Treatment Program

Insomnia Clinical Trial

Official title:

A Study on Online Insomnia Treatment Programs

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05778812
• Other study ID #: 67436
• Status: Recruiting
• Phase: N/A
• Start date: August 11, 2023
• Est. completion date: April 2024

Study information

• Verified date: September 2023
• Source: Koko Home, Inc.
• Contact: Cris Moreno
• Phone: 650-721-7576
• Email: crismore[@]stanford.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: April 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dyssomnias
• Insomnia
• Parasomnias
• Sleep
• Sleep Disorder
• Sleep Disturbance
• Sleep Hygiene
• Sleep Initiation and Maintenance Disorders
• Sleep Wake Disorders

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Stanford Sleep Medicine Center	Redwood City	California

Sponsors (2)

Lead Sponsor	Collaborator
Koko Home, Inc.	Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insomnia Severity Index	A measure of insomnia symptoms	Completion of program (6-8 weeks)
Secondary	Sleep efficiency	The proportion of time sleeping while in bed	Completion of program (6-8 weeks)
Secondary	Wakefulness after sleep onset	# minutes awake after falling asleep	Completion of program (6-8 weeks)
Secondary	Number of awakenings		Completion of program (6-8 weeks)
Secondary	Sleep onset latency	Minutes to fall asleep	Completion of program (6-8 weeks)
Secondary	Total sleep time		Completion of program (6-8 weeks)