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Online Insomnia Treatment Program

A Study on Online Insomnia Treatment Programs

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05778812
Enrollment
200
Registered
2023-03-21
Start date
2023-08-11
Completion date
2024-04-30
Last updated
2023-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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

Interventions

BEHAVIORALFull 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.

BEHAVIORALPath 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.

Sponsors

Stanford University
CollaboratorOTHER
Koko Home, Inc.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Insomnia Severity IndexCompletion of program (6-8 weeks)A measure of insomnia symptoms

Secondary

MeasureTime frameDescription
Sleep efficiencyCompletion of program (6-8 weeks)The proportion of time sleeping while in bed
Wakefulness after sleep onsetCompletion of program (6-8 weeks)\# minutes awake after falling asleep
Number of awakeningsCompletion of program (6-8 weeks)
Sleep onset latencyCompletion of program (6-8 weeks)Minutes to fall asleep
Total sleep timeCompletion of program (6-8 weeks)

Countries

United States

Contacts

Primary ContactCris Moreno
crismore@stanford.edu650-721-7576

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026