Online Insomnia Treatment Program

Last updated: September 12, 2023
Sponsor: Koko Home, Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Insomnia

Sleep Disorders

Restless Leg Syndrome

Treatment

Path to Better Sleep

Full Sleep

Clinical Study ID

NCT05778812
67436
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

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 alertscould be disruptive to partners or others (e.g., children) that sleep in the same room.

Study Design

Total Participants: 200
Treatment Group(s): 2
Primary Treatment: Path to Better Sleep
Phase:
Study Start date:
August 11, 2023
Estimated Completion Date:
April 30, 2024

Study 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

Connect with a study center

  • Stanford Sleep Medicine Center

    Redwood City, California 94063
    United States

    Active - Recruiting

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