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NCT02214212 · ClinicalTrials.gov registry record · NA

TWILIGHT Study: Effect of Light Exposure During Acute Rehabilitation on Sleep After TBI

A NA study, sponsored by University of Washington.

Completed
Registry status
NA
Development phase
131
Enrollment target

NCT02214212: Completed NA study, sponsored by University of Washington.

NCT02214212 is a NA study that has completed, run by University of Washington. The registered enrollment target is 131 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02214212, a NA study, has completed, sponsored by University of Washington.

COMPLETED
Registry status
NA
Development phase
131 participants
Enrollment target

Study Summary

This study proposes to investigate how well Bright White Light Therapy will work in the acute inpatient rehabilitation units for people whom have experienced a traumatic brain injury for the purpose of treating sleep disruption. Participants will be assessed based on sleep efficiency, thinking abilities, therapy participation, and perception of fatigue/sleepiness. In previous studies dim red light has not had the same effects on function as bright white light, and will be chosen for use as a placebo. Each subject will be randomized to receive 30 minutes of either Bright White Light Therapy or Red Light Treatment each morning for 10 days. To measure the effect of this treatment, the investigators will measure the each participants sleep daily by using an actigraph watch. This watch will record movement continuously. The investigators will also measure the subjects' report of how well they slept, whether fatigue is present, and how attentive they are before and after treatment. Research Hypothesis: In persons with TBI, prospectively compare overnight sleep in a cohort exposed to morning Bright White Light with a comparison group exposed to Red Light in an acute inpatient rehabilitation setting.

Primary Outcome

Sleep efficiency scores derived from actigraphy data will be the primary outcome. We will set the Actiwatch to record activity data in 60-second intervals. Actigraphy data will be automatically scored with Actiware software (Respironics, Philips Healthcare), which uses validated algorithms to determine whether an epoch of activity is "sleep" or "wake" (Cole RJ, 1992). Typically there is a lack of a consistent sleep/wake cycle in the study population, therefore we will be using sleep efficiency a

Interventions

  • DEVICE Bright White Light (BWL)
  • DEVICE Red Light (RL)

Trial Details

FieldValue
Enrollment Target 131 participants
Start Date 2013-12
Est. Completion 2017-03
Phase NA
University of Washington

1,048 total trials

What the finished NCT02214212 record still lists

NCT02214212 is an interventional study that assigns participants to a tested intervention. The registered 131 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (91% lower).

The record links to 0 conditions, and to 2 interventions - of which Bright White Light (BWL) is the first listed.

NCT02214212 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02214212 about?

NCT02214212 is a clinical study titled "TWILIGHT Study: Effect of Light Exposure During Acute Rehabilitation on Sleep After TBI". This study proposes to investigate how well Bright White Light Therapy will work in the acute inpatient rehabilitation units for people whom have experienced a traumatic brain injury for the purpose of treating sleep disruption. Participants will be assessed based on sleep efficiency, thinking abili...

What is the current status of trial NCT02214212?

This trial is currently completed. It is a NA study. The enrollment target is 131 participants. The study started on 2013-12. Estimated completion is 2017-03.

What interventions are being tested in trial NCT02214212?

The interventions under investigation include: Bright White Light (BWL) (DEVICE), Red Light (RL) (DEVICE).

Who is sponsoring clinical trial NCT02214212?

This trial is sponsored by University of Washington, which has 1,048 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02214212's enrollment target sits among peer trials

131 732nd of 2000 higher than 1,268 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA 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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Source: ClinicalTrials.gov NCT02214212, the US trial registry maintained by the National Library of Medicine. NCT02214212 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.