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NCT05665764 · ClinicalTrials.gov registry record
The Feasibility of Home-Based Measurement of Circadian Timing for Veterans With TBI and Insomnia
A clinical trial, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- 31
- Enrollment target
NCT05665764: Completed study, sponsored by VA Office of Research and Development.
NCT05665764 is a clinical trial that has completed, run by VA Office of Research and Development. The registered enrollment target is 31 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05665764 has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- 31 participants
- Enrollment target
Study Summary
Veterans with traumatic brain injury (TBI) frequently experience insomnia, which is linked with delayed TBI recovery, more severe functional impairment, and exacerbation of disabling TBI after-effects such as depression, chronic pain, and fatigue. Current research suggests that TBI can impact numerous systems involved in sleep, suggesting that insomnia can have various causes and that a "one-size-fits-all" approach to treatment is likely inadequate. As such, it is necessary to determine which Veterans may benefit from standard evidence-based treatments, such as Cognitive Behavior Therapy for Insomnia, and which may require enhanced treatments targeting specific underlying mechanisms. An emerging body of evidence has established a link between circadian rhythm disruption and post-TBI insomnia. A mismatch between circadian and desired sleep timing (i.e., "circadian misalignment") is common following TBI, as evidenced by disruptions of key circadian rhythms involved in sleep regulation (e.g., melatonin production), as well as the onset of circadian rhythm sleep-wake disorders. Importantly, circadian-driven sleep disturbances require specialized treatments that target circadian rhythms (i.e., "chronotherapies"), such as timed sleep windows or enhanced light exposure, as standard treatment approaches can fail to address or even exacerbate the underlying circadian misalignment. Thus, circadian misalignment represents a novel and modifiable treatment target and has the potential to improve functional outcomes in Veterans with TBI and insomnia. Detection of circadian misalignment and optimal use of chronotherapies require the ability to measure circadian phase (i.e., timing of the central circadian clock). However, current sleep medicine in TBI is hampered by a lack of pragmatic options for measuring circadian phase. This is because laboratory dim light melatonin onset (DLMO), the gold standard measure of circadian phase, is time and cost prohibitive, requiring specialize
Primary Outcome
This outcome will be considered feasible if 70% participants provide adequate data for measurement of dim light melatonin onset (DLMO). DLMO will be estimated via the observed salivary melatonin levels using a variable threshold method, defined as the time of day when melatonin rises above the mean of the individual's first three saliva samples plus two standard deviations of those first three samples. Additionally, adequate data will entail: 1) collection and return of at least 5 saliva samples
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2023-07-01 |
| Est. Completion | 2025-12-31 |
What the finished NCT05665764 record still lists
NCT05665764 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 31 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT05665764 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05665764 about?
NCT05665764 is a clinical study titled "The Feasibility of Home-Based Measurement of Circadian Timing for Veterans With TBI and Insomnia". Veterans with traumatic brain injury (TBI) frequently experience insomnia, which is linked with delayed TBI recovery, more severe functional impairment, and exacerbation of disabling TBI after-effects such as depression, chronic pain, and fatigue. Current research suggests that TBI can impact numero...
What is the current status of trial NCT05665764?
This trial is currently completed. The enrollment target is 31 participants. The study started on 2023-07-01. Estimated completion is 2025-12-31.
Who is sponsoring clinical trial NCT05665764?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
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