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Individually Tailored Lighting System to Improve Sleep in Older Adults

Not Applicable
Completed
Conditions
Sleep Disturbances
Registration Number
NCT01855126
Lead Sponsor
Rensselaer Polytechnic Institute
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
46
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Primary Outcome Measures
NameTimeMethod
Sleep DisturbanceBaseline (week 0) and week 8 of lighting intervention

Pittsburgh Sleep Quality Index. Score range 0 - 21. A score over 5 is indicative of sleep disturbance.

Change in score from baseline to intervention is reported. A larger difference indicates a better outcome.

Sleep Start Timebaseline week (week 0) and the last week of intervention (week 8)

Change in sleep start time, in minutes, from baseline week to the last week of intervention. A higher number is a better outcome. Based on actigraph data

Total Sleep Timebaseline week (week 0) and the last week of intervention (week 8)

The change in total amount of minutes spent sleeping at night from baseline week to the last week of intervention. A higher number is an improved outcome

Sleep Efficiencybaseline week (week 0) and the last week of intervention (week 8)

The change in sleep efficiency from baseline to last week of intervention. A higher number is a better outcome. Sleep efficiency is the percentage of time spent in bed sleeping. Scored total sleep time divided by interval duration minus total invalid time (sleep/wake) of the given rest interval multiplied by 100. This data was collected using actigraphy data.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Rensselaer Polytechnic Institute

🇺🇸

Troy, New York, United States

Rensselaer Polytechnic Institute
🇺🇸Troy, New York, United States

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