Clinical trial NCT01855126: Individually Tailored Lighting System to Improve Sleep in Older Adults
Official title: Individually Tailored Lighting System to Improve Sleep in Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Disturbances
Keywords: light
circadian rhythms
dim light melatonin onset
sleep
Lead sponsor: Rensselaer Polytechnic Institute
Sponsor class: OTHER
Collaborators: name: University of North Carolina
First posted: 2013-05-16
Enrollment: 46
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Enrolled participants will be randomized to receive either the active intervention or placebo intervention and then crossed over to receive the opposite intervention. The study consisted of two intervention periods of 8 weeks separated by a two week washout period.
Primary purpose: TREATMENT

Brief 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

Detailed description: We will recruit 50 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 2-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.

Eligibility criteria: 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

Primary outcomes:
measure: Sleep Disturbance
timeFrame: Baseline (week 0) and week 8 of lighting intervention
measure: Total Sleep Time
timeFrame: baseline week (week 0) and the last week of intervention (week 8)
measure: Sleep Efficiency
timeFrame: baseline week (week 0) and the last week of intervention (week 8)
measure: Sleep Start Time
timeFrame: baseline week (week 0) and the last week of intervention (week 8)
Secondary outcomes:
Other outcomes:
Locations:
city: Troy
country: United States
facility: Rensselaer Polytechnic Institute
state: New York
Study officials:
affiliation: Rensselaer Polytechnic Institute
name: Mariana G Figueiro, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Figueiro MG, Plitnick B, Rea MS. Pulsing blue light through closed eyelids: effects on acute melatonin suppression and phase shifting of dim light melatonin onset. Nat Sci Sleep. 2014 Dec 2;6:149-56. doi: 10.2147/NSS.S73856. eCollection 2014.
citation: Figueiro MG, Bierman A, Rea MS. A train of blue light pulses delivered through closed eyelids suppresses melatonin and phase shifts the human circadian system. Nat Sci Sleep. 2013 Oct 4;5:133-41. doi: 10.2147/NSS.S52203. eCollection 2013.