NCT06867666 (CBTBI) is a NA clinical trial of In Person CBT-I in Insomnia, sponsored by Noctem, LLC.

Who is sponsoring NCT06867666?

NCT06867666 is sponsored by Noctem, LLC.

What drugs are being tested in NCT06867666?

Interventions in NCT06867666: In Person CBT-I, CBT-I via COAST.

What condition does NCT06867666 study?

NCT06867666 studies Insomnia, TBI (Traumatic Brain Injury).

Is NCT06867666 still recruiting?

NCT06867666 is currently recruiting now. Last updated 24 April 2025.

Last reviewed 2025-04-24 · How we verify

NCT06867666: CBTBI

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Behavioral Treatment of Insomnia in Active-Duty Service Members With Traumatic Brain Injury

Recruiting now NA Last updated 24 April 2025

What this trial tests

NA trial testing In Person CBT-I in Insomnia in 168 participants. Currently enrolling.

Timeline

1 April 2025

Primary endpoint
31 January 2027

31 January 2027

Quick facts

Lead sponsor	Noctem, LLC
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	168
Start date	1 April 2025
Primary completion	31 January 2027
Estimated completion	31 January 2027
Sites	1 location across United States

Drugs / interventions tested

In Person CBT-I
CBT-I via COAST

Conditions studied

Insomnia — all drugs for Insomnia →
TBI (Traumatic Brain Injury) — all drugs for TBI (Traumatic Brain Injury) →

Sponsor

Noctem, LLC

Who can join

18 and older, any sex, with Insomnia or TBI (Traumatic Brain Injury). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The objective of the study is to conduct a randomized controlled trial of Cognitive Behavioral Therapy for Insomnia (CBT-I) in a sample of active-duty sailors with a history of traumatic brain injury (TBI). The investigators will test the impact of CBT-I on insomnia symptoms as well as post-concussive symptoms, psychological symptoms, and neurocognitive functioning in comparison to treatment as usual. The investigators will also compare the effectiveness of traditional in-person CBT-I and CBT-I delivered via a clinician-supervised digital health platform, Clinician Operated Assistive Sleep Technology (COAST) in comparison to treatment as usual on symptoms of insomnia, post-concussive symptoms, neurocognitive functioning, and psychological health. Participants will be assessed at baseline, post-treatment, and 3 months later.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Behavioral treatment of insomnia in active-duty service members with traumatic brain injury: study protocol for a randomized clinical trial.
Germain A, Wolfson M, Espejo E, Byrd A, et al · · 2026 · PMID 41630034 · DOI 10.1186/s13063-026-09483-z

Verify or expand the search:

Other recruiting trials for Insomnia

Currently open trials in the same condition.

NCT07384429 — Effects of Lemborexant on Motor-sleep Comorbidity in Parkinson's Disease · Phase 4 · recruiting
NCT07270406 — Healthy Behaviors for Insomnia Prevention in People With HIV and Ongoing Pain · NA · recruiting
NCT07071324 — CF Wellness Program · NA · recruiting
NCT07417813 — A Multicenter Observational Study of Lemborexant on Insomnia Patients With Psychiatric Disorders · recruiting
NCT06348082 — Project Women's Insomnia Sleep Health Equity Study (WISHES) · NA · recruiting

Other Noctem, LLC trials

Trials by the same sponsor.

NCT04366284 — Optimizing the Scalability of Evidence-Based Behavioral Sleep Medicine Practices With a Digital Health Platform · NA · unknown

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT06867666 (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 Noctem, LLC
Last refreshed: 24 April 2025

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/NCT06867666.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing