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NCT06867666 · ClinicalTrials.gov registry record · NA
Behavioral Treatment of Insomnia in Active-Duty Service Members With Traumatic Brain Injury
A NA study of Insomnia and TBI (Traumatic Brain Injury), sponsored by Noctem.
- Recruiting
- Registry status
- NA
- Development phase
- 168
- Enrollment target
- 1
- Study location
NCT06867666: Recruiting NA study of Insomnia and TBI (Traumatic Brain Injury), sponsored by Noctem.
NCT06867666 is a NA study of Insomnia and TBI (Traumatic Brain Injury) that is actively recruiting participants, run by Noctem. The registered enrollment target is 168 participants, roughly in line with the 169-participant average among 151 other Insomnia trials with a reported enrollment target. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06867666, a NA study of Insomnia and TBI (Traumatic Brain Injury), is actively recruiting participants, sponsored by Noctem.
- RECRUITING
- Registry status
- NA
- Development phase
- 168 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
The Insomnia Severity Index is a 7-item self-report questionnaire that assesses subjective severity of insomnia symptoms, degree of satisfaction with sleep, nature and noticeability of daytime impairments, and concerns caused by sleep difficulties. Each item is rated on a 0 to 4-point scale. A cut-off score of 14 has been shown to optimize sensitivity and specificity. Scores from 0 to 7 reflect clinically insignificant insomnia; scores from 8 to 14 reflects subthreshold insomnia; scores from 15
Conditions Studied
Interventions
- BEHAVIORAL In Person CBT-I
- BEHAVIORAL CBT-I via COAST
Study Locations (1)
California
- Naval Medical Center San Diego - San Diego
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 168 participants |
| Start Date | 2025-04-01 |
| Est. Completion | 2027-01-31 |
| Phase | NA |
What NCT06867666 shows while recruiting
NCT06867666 is an interventional study that assigns participants to a tested intervention. The registered 168 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 169-participant average among 151 other Insomnia trials with a reported enrollment target.
The record links to 2 conditions, with Insomnia appearing as the primary indexed condition, and to 2 interventions - of which In Person CBT-I is the first listed.
NCT06867666 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT06867666 about?
NCT06867666 is a clinical study titled "Behavioral Treatment of Insomnia in Active-Duty Service Members With Traumatic Brain Injury". 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-concussi...
What is the current status of trial NCT06867666?
This trial is currently recruiting. It is a NA study. The enrollment target is 168 participants. The study started on 2025-04-01. Estimated completion is 2027-01-31.
What conditions does trial NCT06867666 study?
This clinical trial studies the following conditions: Insomnia, TBI (Traumatic Brain Injury).
What interventions are being tested in trial NCT06867666?
The interventions under investigation include: In Person CBT-I (BEHAVIORAL), CBT-I via COAST (BEHAVIORAL).
Who is sponsoring clinical trial NCT06867666?
This trial is sponsored by Noctem, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06867666 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06867666's enrollment target sits among peer trials
168 42nd of 151 higher than 110 of 151 other Insomnia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Insomnia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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