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NCT05541055: CrEDIT
Digital CBT-I for Insomnia Disorder
NA trial testing digital CBT-I in Insomnia Disorder in 336 participants. Completed in 24 August 2023.
15 May 2023
Quick facts
| Lead sponsor | Big Health Inc. |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 336 |
| Start date | 8 November 2022 |
| Primary completion | 15 May 2023 |
| Estimated completion | 24 August 2023 |
| Sites | 1 location across United States |
Drugs / interventions tested
- digital CBT-I
- Sleep hygiene education
Conditions studied
- Insomnia Disorder — all drugs for Insomnia Disorder →
Sponsor
Big Health Inc.
Who can join
22 and older, any sex, with Insomnia Disorder. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
The Effectiveness of Digital Cognitive Behavioral Therapy to Treat Insomnia Disorder in US Adults: Nationwide Decentralized Randomized Controlled Trial.
Prather AA, Krystal AD, Emsley R, Carl J, et al · · 2025 · PMID 41343796 · DOI 10.2196/84323
Verify or expand the search:
- PubMed search for NCT05541055
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of digital CBT-I
Trials testing the same drug.
- NCT05568381 — Sleep Disturbance in MCI: A Study of a Cognitive Behavioural Therapy Digital Intervention · NA · completed
Other recruiting trials for Insomnia Disorder
Currently open trials in the same condition.
- NCT06767137 — Comparative Efficacy of BRT and CBT-I for Insomnia · NA · recruiting
- NCT06626048 — Optimizing an Integrated Mind and Body Treatment for Insomnia: The SLEEPS Study · NA · active not recruiting
- NCT06669507 — The Sleep Clinic Outcome and Practice Study · NA · recruiting
- NCT06335784 — Mental Imagery and Targeted Memory Reactivation in Insomnia · NA · recruiting
- NCT05924425 — Daridorexant to Treat Insomnia in Patients With Mild Cognitive Impairment and Mild to Moderate Alzheimer Disease · Phase 4 · recruiting
Other Big Health Inc. trials
Trials by the same sponsor.
- NCT06003361 — Rise Study for Depression · NA · completed
- NCT05748652 — Generalized Anxiety Therapy Effectiveness · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05541055 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Big Health Inc.
- Last refreshed: 15 April 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05541055.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing