Overview

This trial is active, not recruiting.

Condition sleep disturbances
Treatments blue light, red light
Phase phase 1
Sponsor Rensselaer Polytechnic Institute
Collaborator University of North Carolina
Start date March 2013
End date December 2016
Trial size 28 participants
Trial identifier NCT01855126, R01AG042602

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model crossover assignment
Masking double blind (subject, caregiver, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Participants will wear an actigraph for 2 weeks prior to coming to the lab for phase assessment. Participants will provide saliva samples for dim light melatonin onset (DLMO). The DLMO data from this baseline week, in conjunction with the Dimesimeter data will determine the time of light administration during weeks 6 and 9. There will be 2 weeks "off" between experimental sessions. During weeks 6 and 9 participants will be wearing the light measuring and delivery system, which is composed of the Dimesimeter, a computer, and the light mask. The light mask (red or blue) will be automatically programmed to be turned on for 120 min at the appropriate time for that evening, based on the feedback from the Dimesimeter data.
blue light
On week 6, half of the subjects will be given light masks that deliver blue light before the estimated CBTmin and the other half will be exposed to red light under identical conditions - placebo control. On week 9, the ones who experienced blue light on week 6 will experience the red light, while the ones who experienced the red light on week 6 will experience the blue light on week 9. If subjects awaken while the mask is on, they will be instructed to try to fall asleep again or to stay in bed with their eyes closed. 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.
(Placebo Comparator)
Participants will wear an actigraph for 2 weeks prior to coming to the lab for phase assessment. Participants will provide saliva samples for dim light melatonin onset (DLMO). The DLMO data from this baseline week, in conjunction with the Dimesimeter data will determine the time of light administration during weeks 6 and 9. There will be 2 weeks "off" between experimental sessions. During weeks 6 and 9 participants will be wearing the light measuring and delivery system, which is composed of the Dimesimeter, a computer, and the light mask. The light mask (red or blue) will be automatically programmed to be turned on for 120 min at the appropriate time for that evening, based on the feedback from the Dimesimeter data.
red light
On week 6, half of the subjects will be given light masks that deliver blue light before the estimated CBTmin and the other half will be exposed to red light under identical conditions - placebo control. On week 9, the ones who experienced blue light on week 6 will experience the red light, while the ones who experienced the red light on week 6 will experience the blue light on week 9. If subjects awaken while the mask is on, they will be instructed to try to fall asleep again or to stay in bed with their eyes closed. The light mask will always be turned on 120 min before estimated CBTmin; it is expected that blue light exposure will delay the timing of the CBTmin.

Primary Outcomes

Measure
Circadian phase shift
time frame: Three times during the study: Baseline (week 0), intervention (week 3) and placebo (week 6)

Secondary Outcomes

Measure
Epworth Sleepiness Scale
time frame: Once a day prior to bedtime for 3 weeks: baseline week, intervention week and placebo week

Eligibility Criteria

Male or female participants at least 65 years old.

Inclusion Criteria: - age 65 or older - cognitively capable - able to respond to study staff verbally and in English - score greater than 6 using the Pittsburgh Sleepiness Quality Index - suffer from insomnia - suffer from excessive daytime sleepiness Exclusion Criteria: - Severe sleep apnea - Severe restless leg syndrome (RLS) - Significant cognitive impairment - History of severe photosensitivity dermatitis

Additional Information

Official title Individually Tailored Lighting System to Improve Sleep in Older Adults
Principal investigator Mariana G Figueiro, PhD
Description We will recruit 28 subjects who report going to bed early and desiring later bedtimes and will ask them to wear an active and an inactive light mask for 8 consecutive weeks each. A 4-week washout period between active and inactive conditions will be applied. Outcome measures will be collected periodically throughout the 8 weeks. Baseline (no intervention) will be collected prior to the active and inactive lighting interventions.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Rensselaer Polytechnic Institute.