---
title: Digital CBT-I for Insomnia Disorder
nct_id: NCT05541055
overall_status: COMPLETED
phase: NA
sponsor: Big Health Inc.
study_type: INTERVENTIONAL
primary_condition: Insomnia Disorder
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT05541055.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT05541055"
ct_last_update_post_date: 2024-04-15
last_seen_at: "2026-05-12T07:32:29.914Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Digital CBT-I for Insomnia Disorder

**Official Title:** Clinical Effectiveness of Digital CBT-I for the Treatment of Insomnia Disorder: A Randomized Controlled Trial

**NCT ID:** [NCT05541055](https://clinicaltrials.gov/study/NCT05541055)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 336
- **Lead Sponsor:** Big Health Inc.
- **Collaborators:** University of California, San Francisco
- **Conditions:** Insomnia Disorder
- **Start Date:** 2022-11-08
- **Completion Date:** 2023-08-24
- **CT.gov Last Update:** 2024-04-15

## Brief 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.

## Detailed Description

This study aims to examine the effectiveness of a fully-automated web and app-based digital CBT-I for insomnia compared to sleep hygiene education (SHE) in individuals with a diagnosis of insomnia disorder. Primary outcomes of interest include changes in insomnia severity, sleep onset latency, and wake after sleep onset throughout the course of the study.

## Eligibility

- **Minimum age:** 22 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* Age ≥22 years old
* Insomnia Disorder diagnosis
* Score ≤16 on the 8-item Sleep Condition Indicator
* \> 30 minutes sleep onset latency (SOL); and/or \> 30 minutes wake after sleep onset (WASO)
* Current resident of the USA
* Oral and written fluency in English
* Participant is able and willing to comply with protocol requirements, has been informed of the nature of the study, and has signed the IRB-approved informed consent form

Exclusion Criteria:

* Must not be currently receiving or be expecting to start CBT for insomnia during study participation, or have previously received CBT for insomnia in the past 12-months (self-report)
* If on psychoactive medication, including sleep medication, this must be stable for at least 5 half lives
* Past or present psychosis, schizophrenia, bipolar disorder, assessed by self-report and/or seizure disorder
* Occupation that requires alertness / caution to avoid accidents, for example long-haul driving, long distance bus driver, heavy machinery operator, air traffic controller
* Hearing or vision impairment that prevents effective use of the audio-visual content of digital CBT-I or SHE in the opinion of the investigator
* Intellectual disability or any Neurocognitive or Neurodevelopmental disorder that would prevent participants from following study procedures
* Any condition that the investigator believes would make participation in the study not in the best interest of the participant or would preclude successful completion of study activities
```

## Arms

- **Digital CBT-I** (EXPERIMENTAL) — Digitally-delivered CBT for insomnia accessed via web and/or mobile app
- **Sleep hygiene education** (ACTIVE_COMPARATOR) — This group will receive access to sleep hygiene education delivered via digital written materials

## Interventions

- **digital CBT-I** (DEVICE) — A fully-automated and personalized digital intervention based on principles from cognitive behavioral therapy for insomnia.
- **Sleep hygiene education** (OTHER) — 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.

## Primary Outcomes

- **Change in the Insomnia Severity Index (ISI)** _(time frame: From baseline to 10 weeks post-randomization)_ — Validated questionnaire; a 7-item scale with total scores between 0 and 28 where higher scores indicate greater severity
- **Change in sleep onset latency (SOL)** _(time frame: From baseline to 10 weeks post-randomization)_ — Measured by daily sleep diaries (based on the Consensus Sleep Diary) averaged across 10 days
- **Change in wake after sleep onset (WASO)** _(time frame: From baseline to 10 weeks post-randomization)_ — Measured by daily sleep diaries (based on the Consensus Sleep Diary) averaged across 10 days

## Secondary Outcomes

- **Insomnia Disorder remission (score <8) and response (change ≥6) on the ISI** _(time frame: 10, 16, and 24 weeks post-randomization)_
- **Insomnia disorder remission based on the SCID Insomnia Module** _(time frame: Week -1 compared to weeks 10, 16, and 24 post-randomization)_
- **Change in sleep diary parameters: percent sleep efficiency (SE), total sleep time (TST), total time in bed (TTIB), and total wake time (TWT)** _(time frame: From lead-in period to 10, 16, and 24 weeks post-randomization)_
- **Change in the Sleep Condition Indicator (SCI-8)** _(time frame: From baseline to weeks 10, 16, and 24 post-randomization)_
- **Change in the Generalized Anxiety Disorder Questionnaire (GAD-7)** _(time frame: From baseline to weeks 10, 16, and 24 post-randomization)_
- **Change in the Patient Health Questionnaire (PHQ-8)** _(time frame: From baseline to weeks 10, 16 and 24 post-randomization)_
- **Change in the Insomnia Severity Index (ISI)** _(time frame: From baseline to weeks 16 and 24 post-randomization)_
- **Change in sleep onset latency (SOL)** _(time frame: From baseline to weeks 16 and 24 post-randomization)_
- **Change in wake after sleep onset (WASO)** _(time frame: From baseline to weeks 16 and 24 post-randomization)_

## Locations (1)

- University of California, San Francisco, San Francisco, California, United States

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.university of california, san francisco|san francisco|california|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT05541055.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT05541055*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*