Online program for treating insomnia
A Study on Online Insomnia Treatment Programs
This study is testing whether two different online programs for treating insomnia can help people sleep better, and if adding a bedside device makes a difference.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Koko Home, Inc. Industry-sponsored |
| Locations | 1 site (Redwood City, California) |
| Trial ID | NCT05778812 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of two 6-week digital programs that deliver Cognitive Behavioral Therapy for Insomnia (CBT-I), comparing an online format to an app-based format. Participants will complete a daily sleep diary and engage with the CBT-I content for approximately 15 minutes each day. The study aims to determine if the addition of a bedside device for tracking sleep enhances the treatment outcomes for individuals with insomnia.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a diagnosis of insomnia or suspected insomnia who have access to the internet and a compatible smartphone.
Not a fit: Patients with conditions such as sleep apnea, narcolepsy, or severe mental health issues may not benefit from this program.
Why it matters
Potential benefit: If successful, this program could significantly improve sleep quality for patients suffering from insomnia.
How similar studies have performed: Other studies have shown success with digital CBT-I programs, indicating a promising approach to treating insomnia.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Redwood City, California
- Stanford Sleep Medicine Center — Redwood City, California, United States (Recruiting)
Study contacts
- Study coordinator: Cris Moreno
- Email: crismore@stanford.edu
- Phone: 650-721-7576
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.