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RECRUITING NA

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

NCT06867666 · View on ClinicalTrials.gov ↗

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.

Interventions

  • BEHAVIORAL In Person CBT-I
  • BEHAVIORAL CBT-I via COAST

Study Locations (1)

California

  • Naval Medical Center San Diego — San Diego

Trial Details

FieldValue
Enrollment Target 168 participants
Start Date 2025-04-01
Est. Completion 2027-01-31
Phase NA

Sponsor

Noctem

2 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06867666

The ClinicalTrials.gov registry entry for NCT06867666 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 168 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Noctem, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06867666 reports 1 study location spanning 1 distinct geographic area — top geographies include California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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). These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06867666?

The interventions under investigation include: In Person CBT-I (BEHAVIORAL), CBT-I via COAST (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06867666?

This trial is sponsored by Noctem, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial