Online Insomnia Treatment Program

NCT ID: NCT05778812

Last Updated: 2023-09-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-11
• Study Completion Date: 2024-04-30

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

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Full Sleep

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.

Group Type: EXPERIMENTAL

Full Sleep

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

Path to Better Sleep

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Stanford University

OTHER

Sponsor Role: collaborator

Koko Home, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Stanford Sleep Medicine Center

Redwood City, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Cris Moreno

Role: CONTACT

crismore@stanford.edu

650-721-7576

Facility Contacts

Cris Moreno

Role: primary

crismore@stanford.edu

650-721-7576

Other Identifiers

67436

Identifier Type: -

Identifier Source: org_study_id