Ignite Creation Date:
2024-07-17 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06477796
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-27
First Post:
2024-06-21
Brief Title:
Improving Sleep in Veterans With the Polytrauma Clinical Triad
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
A Sleep Intervention to Improve Quality of Life and Symptom Management in Veterans With the Polytrauma Clinical Triad
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LIONv2
Brief Summary:
The polytrauma clinical triad PCT a highly disabling constellation of factors is defined by the coexistence of traumatic brain injury post-traumatic stress disorder and chronic pain Veterans with the PCT are medically complex often refractory to conventional therapies and suffer from additional related chronic sequela Notably sleep disturbances and cognitive impairment which the investigators hypothesize are significant contributing factors to these functional impairments and an impediment toward rehabilitation Thus the investigators research aims to intervene at the level of sleep and by improving sleep improve these interconnected disabling and difficult to treat enduring complexities associated with the PCT - ultimately to improve Veteran quality of life functional independence and restorative function The investigators predict that the proposed intervention morning bright light therapy which is cost-effective rapidly deployable and home-based will be effective in improving sleep and overall PCT symptom management thereby resulting in a measurable and impactful improvement in quality of life
Detailed Description:
The co-existence of traumatic brain injury post-traumatic stress disorder PTSD and chronic pain defines the clinical entity referred to as the polytrauma clinical triad PCT Well recognized to be highly prevalent and disabling in US military service members and Veterans those with the PCT are traditionally viewed as the most disabled cases and most refractory to conventional therapies Central to the challenge in effectively treating Veterans with the PCT is the bi-directional mutually reinforcing relationship between these conditions Further complicating is the influence of sleep and cognitive impairment both of which are widely regarded as primary contributing chronic sequela associated with the PCT The specific contribution from sleep in exacerbating this clinical picture is supported by extensive scientific precedent demonstrating impairments in sleep intensify and worsen these related sequela eg cognitive impairment pain management and PTSD symptom severity which in turn contribute to further impairment in sleep Accordingly an effective intervention targeting sleep may alleviate rehabilitative pressure on these associated sequelae and facilitate breaking out of this vicious cycle ie poor sleep exacerbating outcomes and in turn further impairing sleep
Recent work from the investigators laboratory demonstrate promise for a simple at home non-pharmacologic and cost-effective sleep focused intervention morning bright light therapy MBLT The investigators have demonstrated robust feasibility acceptability and limited efficacy for MBLT to improve sleep and thereby improve cognitive function PCT symptom management and overall quality of life in this medically complex and vulnerable population Accordingly this proposal aims to extend the foundational work from the CDA-2 to inform a prospective phase II placebo-controlled randomized clinical trial examining effectiveness for MBLT as a sleep- based intervention in Veterans with the PCT
Specific aims designed to test this hypothesis are to determine effectiveness for MBLT to improve 1 sleep 2 cognition and 3 PCT symptom management in Veterans with the PCT The investigators propose to enroll n138 Veterans randomized 21 to MBLT 10000 lux light exposure for 60 min within 120 min of waking for 4-weeks or a no- light sham-MBLT condition as previously published using the same durationtiming Sleep cognition and PCT symptom management will be assessed through a novel combination of subjectiveself-report objective measures and ecological momentary assessment sampling Specific objective assessments include wrist- based actigraphy and as exploratory outcome in a sub-set of participants home-based overnight polysomnography Outcomes will be assessed pre- and post-intervention with follow-up at 6- and 12-weeks post-intervention
It is expected the proposed work will demonstrate effectiveness for MBLT to improve sleep cognition and PCT symptom management including ameliorating chronic pain and improving quality of life in Veterans with the PCT This project will demonstrate 1 an effective treatment option alone or in combination with existing rehabilitative efforts in Veterans with the PCT and 2 sleep-wake disturbances may be implicated in the pathogenesis of these functional impairments thereby establishing greater precedent for targeting sleep as a meaningful primary andor adjunctive rehabilitative therapy
Recent work from the investigators laboratory demonstrate promise for a simple at home non-pharmacologic and cost-effective sleep focused intervention morning bright light therapy MBLT The investigators have demonstrated robust feasibility acceptability and limited efficacy for MBLT to improve sleep and thereby improve cognitive function PCT symptom management and overall quality of life in this medically complex and vulnerable population Accordingly this proposal aims to extend the foundational work from the CDA-2 to inform a prospective phase II placebo-controlled randomized clinical trial examining effectiveness for MBLT as a sleep- based intervention in Veterans with the PCT
Specific aims designed to test this hypothesis are to determine effectiveness for MBLT to improve 1 sleep 2 cognition and 3 PCT symptom management in Veterans with the PCT The investigators propose to enroll n138 Veterans randomized 21 to MBLT 10000 lux light exposure for 60 min within 120 min of waking for 4-weeks or a no- light sham-MBLT condition as previously published using the same durationtiming Sleep cognition and PCT symptom management will be assessed through a novel combination of subjectiveself-report objective measures and ecological momentary assessment sampling Specific objective assessments include wrist- based actigraphy and as exploratory outcome in a sub-set of participants home-based overnight polysomnography Outcomes will be assessed pre- and post-intervention with follow-up at 6- and 12-weeks post-intervention
It is expected the proposed work will demonstrate effectiveness for MBLT to improve sleep cognition and PCT symptom management including ameliorating chronic pain and improving quality of life in Veterans with the PCT This project will demonstrate 1 an effective treatment option alone or in combination with existing rehabilitative efforts in Veterans with the PCT and 2 sleep-wake disturbances may be implicated in the pathogenesis of these functional impairments thereby establishing greater precedent for targeting sleep as a meaningful primary andor adjunctive rehabilitative therapy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| I01RX004822 | OTHER_GRANT | None | None |