Online Insomnia Treatment Program for Insomnia

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Koko Home, Inc.

No Placebo Group

Trial Summary

What is the purpose of this trial?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

This trial is for adults over 18 with moderate to severe insomnia who have access to an iPhone or Android phone. They must be able to dedicate 15 minutes daily to the program. People can't join if they work shifts, sleep with pets, have certain sleep disorders like apnea or narcolepsy, serious mental/physical issues, substance abuse problems, or are on recent antidepressant medication changes.

Inclusion Criteria

Access to an iPhone with iOS 11+ or Samsung, Google, HTC, LG, OnePlus, or Motorola phone with Android 10+

I can dedicate 15 minutes daily to participate.

I am 18 years old or older.

+1 more

Exclusion Criteria

I am at risk of falling or considered frail.

You have serious issues with remembering things.

You have a history of using drugs or alcohol in a harmful way.

+11 more

Participant Groups

The study compares two digital Cognitive Behavioral Therapy programs for insomnia lasting six weeks each: 'Full Sleep' and 'Path to Better Sleep'. One may include a device that tracks sleep at bedside. Participants will use either an online platform or app-based service designed for improving sleep quality.

2Treatment groups

Experimental Treatment

Active Control

Group I: Full SleepExperimental Treatment1 Intervention

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 II: Path to Better SleepActive Control1 Intervention

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.