Online Insomnia Treatment Program

NCT05778812 | Unknown

• 1 other identifier: 67436
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Insomnia Severity Index

  A measure of insomnia symptoms

  Completion of program (6-8 weeks)

Secondary Outcomes (5)

• Sleep efficiency

  Completion of program (6-8 weeks)

• Wakefulness after sleep onset

  Completion of program (6-8 weeks)

• Number of awakenings

  Completion of program (6-8 weeks)

• Sleep onset latency

  Completion of program (6-8 weeks)

• Total sleep time

  Completion of program (6-8 weeks)

Study Arms (2)

Full Sleep

EXPERIMENTAL

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

Path to Better Sleep

ACTIVE COMPARATOR

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

Interventions

Full Sleep BEHAVIORAL

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.

Full Sleep

Path to Better Sleep BEHAVIORAL

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.

Path to Better Sleep

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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+
• years of age or older
• available 15 mins per day to participate

You may not qualify if:

• 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.

Sponsors & Collaborators

• Koko Home, Inc.: lead
• Stanford University: collaborator

Study Sites (1)

Stanford Sleep Medicine Center

Redwood City, California, 94063, United States

RECRUITING

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Parasomnias; Sleep Wake Disorders; Sleep Hygiene

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Nervous System Diseases; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Health Behavior; Behavior

Central Study Contacts

Cris Moreno

CONTACT

650-721-7576; crismore@stanford.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2023
• First Posted: March 21, 2023
• Study Start: August 11, 2023
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2024
• Last Updated: September 14, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)