Individually Tailored Lighting System to Improve Sleep in Older Adults

Sleep Disturbances Clinical Trial

Official title:

Individually Tailored Lighting System to Improve Sleep in Older Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01855126
• Other study ID #: R01AG042602
• Status: Completed
• Phase: N/A
• Start date: March 2013
• Est. completion date: April 2017

Study information

• Verified date: January 2019
• Source: Rensselaer Polytechnic Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: April 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dyssomnias
• Parasomnias
• Sleep Disturbances
• Sleep Wake Disorders

Intervention

Other:
• Blue light
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 light
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.

Locations

Country	Name	City	State
United States	Rensselaer Polytechnic Institute	Troy	New York

Sponsors (2)

Lead Sponsor	Collaborator
Rensselaer Polytechnic Institute	University of North Carolina

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sleep Disturbance	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.	Baseline (week 0) and week 8 of lighting intervention
Primary	Total Sleep Time	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	baseline week (week 0) and the last week of intervention (week 8)
Primary	Sleep Efficiency	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.	baseline week (week 0) and the last week of intervention (week 8)
Primary	Sleep Start Time	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	baseline week (week 0) and the last week of intervention (week 8)