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Clinical Trials/NCT05778812
NCT05778812
Recruiting
Not Applicable

A Study on Online Insomnia Treatment Programs

Koko Home, Inc.1 site in 1 country200 target enrollmentAugust 11, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Insomnia
Sponsor
Koko Home, Inc.
Enrollment
200
Locations
1
Primary Endpoint
Insomnia Severity Index
Status
Recruiting
Last Updated
2 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
August 11, 2023
End Date
April 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Koko Home, Inc.
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Insomnia Severity Index

Time Frame: Completion of program (6-8 weeks)

A measure of insomnia symptoms

Secondary Outcomes

  • Number of awakenings(Completion of program (6-8 weeks))
  • Total sleep time(Completion of program (6-8 weeks))
  • Sleep onset latency(Completion of program (6-8 weeks))
  • Sleep efficiency(Completion of program (6-8 weeks))
  • Wakefulness after sleep onset(Completion of program (6-8 weeks))

Study Sites (1)

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