N/A
N=46
Individually Tailored Lighting System to Improve Sleep in Older Adults
Sleep Disturbances
Bottom Line
View on ClinicalTrials.gov: NCT01855126 ↗Enrolled (actual)
46
Serious AEs
0.0%
Results posted
Jan 2019
Primary outcome: Primary: Sleep Disturbance — -1.9; -1.3 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Blue light (Other); Red light (Other)
- Age
- Older Adult · 65+ yrs
- Sex
- All
- Sponsor
- Rensselaer Polytechnic Institute
- Primary completion
- Apr 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sleep Disturbance |
-1.9; -1.3 | — |
| PRIMARY Total Sleep Time |
4; 1 | — |
| PRIMARY Sleep Efficiency |
1.3; -0.6 | — |
| PRIMARY Sleep Start Time |
9; 1 | — |
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
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
Data sourced from ClinicalTrials.gov (NCT01855126). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.