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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up completion of program (6-8 weeks)
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
Select...
I am 18 years old or older.
Select...
I have been diagnosed with moderate to severe insomnia.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Insomnia Severity Index
Secondary outcome measures
Number of awakenings
Sleep efficiency
Sleep onset latency
+2 more

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.

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Who is running the clinical trial?

Koko Home, Inc.Lead Sponsor
Stanford UniversityOTHER
2,386 Previous Clinical Trials
17,333,808 Total Patients Enrolled
7 Trials studying Sleep
51,101 Patients Enrolled for Sleep

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are being included in this investigation?

"Affirmative. According to the clinicaltrials.gov listing, this experiment is accepting new participants as of September 12th 2023 and has been recruiting since August 11th 2023. 200 individuals are needed across a single location for completion of the trial."

Answered by AI

Are there any vacancies within the scope of this clinical trial?

"Affirmative. By visiting clinicaltrials.gov, one can verify that this medical research initiative is currently recruiting participants. It was originally posted on August 11th 2023 and last updated on September 12th of the same year; they are looking for 200 patients from 1 site in total."

Answered by AI

Who else is applying?

What site did they apply to?
Stanford Sleep Medicine Center
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

I need help with my insomnnia.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
Online Insomnia Treatment Program
2023. "Online Insomnia Treatment Program". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05778812.
All > Insomnia
~120 spots leftby Apr 2025
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