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Online Insomnia Treatment Program

Primary Purpose

Insomnia, Sleep, Sleep Disturbance

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Full Sleep
Path to Better Sleep
Sponsored by
Koko Home, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insomnia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Stanford Sleep Medicine CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Full Sleep

Path to Better Sleep

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Insomnia Severity Index
A measure of insomnia symptoms

Secondary Outcome Measures

Sleep efficiency
The proportion of time sleeping while in bed
Wakefulness after sleep onset
# minutes awake after falling asleep
Number of awakenings
Sleep onset latency
Minutes to fall asleep
Total sleep time

Full Information

First Posted
March 10, 2023
Last Updated
September 12, 2023
Sponsor
Koko Home, Inc.
Collaborators
Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT05778812
Brief Title
Online Insomnia Treatment Program
Official Title
A Study on Online Insomnia Treatment Programs
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 11, 2023 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Koko Home, Inc.
Collaborators
Stanford University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia, Sleep, Sleep Disturbance, Sleep Disorder, Sleep Hygiene, Sleep Initiation and Maintenance Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Full Sleep
Arm Type
Experimental
Arm Description
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.
Arm Title
Path to Better Sleep
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Full Sleep
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Path to Better Sleep
Intervention Description
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.
Primary Outcome Measure Information:
Title
Insomnia Severity Index
Description
A measure of insomnia symptoms
Time Frame
Completion of program (6-8 weeks)
Secondary Outcome Measure Information:
Title
Sleep efficiency
Description
The proportion of time sleeping while in bed
Time Frame
Completion of program (6-8 weeks)
Title
Wakefulness after sleep onset
Description
# minutes awake after falling asleep
Time Frame
Completion of program (6-8 weeks)
Title
Number of awakenings
Time Frame
Completion of program (6-8 weeks)
Title
Sleep onset latency
Description
Minutes to fall asleep
Time Frame
Completion of program (6-8 weeks)
Title
Total sleep time
Time Frame
Completion of program (6-8 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cris Moreno
Phone
650-721-7576
Email
crismore@stanford.edu
Facility Information:
Facility Name
Stanford Sleep Medicine Center
City
Redwood City
State/Province
California
ZIP/Postal Code
94063
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cris Moreno
Phone
650-721-7576
Email
crismore@stanford.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Online Insomnia Treatment Program

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