CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 46 enrolled
Drug / intervention
Blue light +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01855126
NCT01855126N/ACompleted

Individually Tailored Lighting System to Improve Sleep in Older Adults

Rensselaer Polytechnic Institute·interventional·Posted May 16, 2013·Updated Jan 29, 2019

In Brief

A clinical study evaluating Blue light and Red light for Sleep Disturbances. Completed, enrolled 46 participants across 1 site.

Detailed Summary

In conjunction with investigators at the Cecil G. Sheps Center for Health Services Research, University of North Carolina (UNC) at Chapel Hill, we propose to develop and evaluate a low-cost, minimally obtrusive device that delivers individualized light therapy to adults with early-awakening insomnia - the most common sleep disturbance in older adults, and a significant problem because of its relationship to daytime sleepiness, use of potentially hazardous sleep medication, and reduced quality of life. The proposed device will measure light/dark exposure data over 24 hours, estimate optimum timing for light delivery, and deliver an individualized light dosage while subjects are asleep. Light applied through closed eyelids in the early part of the night will delay the dim light melatonin onset, a marker of the circadian clock, and help those with early sleep onset to fall asleep later

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedMay 16, 2013
Enrollment StartMar 1, 2013
Primary CompletionApr 1, 2017
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 13.1 years ago

Interventions

Blue lightother

After a two week baseline collection period, half of the subjects will initially be given light masks that deliver blue light through the closed eyelids, while subjects are sleeping. The light mask will always be turned on 120 min before estimated core body temperature minimum (CBTmin); it is expected that blue light exposure will delay the timing of the CBTmin.

Red lightother

After a two week baseline collection period, half of the subjects will initially be given light masks that deliver red light through the closed eyelids, while subjects are sleeping. The light mask will always be turned on 120 min before estimated core body temperature minimum (CBTmin); it is expected that red light exposure will have no effect on the timing of the CBTmin.