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Online Insomnia Treatment Program for Insomnia

N/A

Recruiting

Research Sponsored by Koko Home, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

18 years of age or older

Insomnia diagnosis or measure-confirmed moderate to severity insomnia (Insomnia Severity Index = 15-28)

Must not have

Sleep apnea

Narcolepsy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up completion of program (6-8 weeks)

Awards & highlights

No Placebo-Only Group

Summary

This trial is researching if digital programs & a bedside device can improve sleep using the best known treatment for insomnia - Cognitive Behavioural Therapy.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves non-medical interventions focusing on behavior therapy and possibly using a tracking device, there are no direct medical side effects expected from participation in the study.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I have been diagnosed with moderate to severe insomnia.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have sleep apnea.

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I have been diagnosed with narcolepsy.

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I have a seizure disorder.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ completion of program (6-8 weeks)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~completion of program (6-8 weeks)

This trial's timeline: 3 weeks for screening, Varies for treatment, and completion of program (6-8 weeks) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Insomnia Severity Index

Secondary study objectives

Sleep efficiency

Sleep onset latency

Wakefulness after sleep onset

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

0 / 5Eligibility criteria met