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Digital CBT-I for Insomnia Disorder

NCT05541055 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 336

Last updated 2024-04-15

No results posted yet for this study

Summary

This study will examine the effectiveness of digital CBT-I versus sleep hygiene education in reducing insomnia severity, sleep onset latency, and wake after sleep onset in those with insomnia disorder.

Conditions

  • Insomnia Disorder

Interventions

DEVICE

digital CBT-I

A fully-automated and personalized digital intervention based on principles from cognitive behavioral therapy for insomnia.

OTHER

Sleep hygiene education

Participants will be provided with sleep hygiene advice which will be delivered digitally all at once upon allocation to the SHE arm. Participants will be able to revisit content during the trial as they wish.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-08
Primary Completion
2023-05-15
Completion
2023-08-24
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05541055 on ClinicalTrials.gov