Individually Tailored Lighting System to Improve Sleep in Older Adults

Rensselaer Polytechnic Institute

Status: Completed

Conditions: Sleep Disturbances

Treatments: Other: Red light; Other: Blue light

Study type: Interventional

Funder types: Other

Identifiers

NCT01855126

R01AG042602

Details and patient eligibility

About

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

Full 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.

Enrollment: 46 patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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46 participants in 2 patient groups, including a placebo group

Blue light

Experimental group

Description:

The study protocol consisted of two 8-week intervention/control periods in which each participant wore either the intervention (blue light) or control (red light) mask every night, with the order of presentation of the two conditions randomized by the study's biostatistician. A light mask housing two blue Light Emitting Diodes (LED) arrays delivered a train of blue or red light pulses of 2 second duration that were presented every 30 s for no longer than 2 hr, resulting in a maximum total of approximately 240 pulses per night. the blue light mask was worn nightly for 8 weeks. There will be a two week washout period between each intervention

Treatment:

Other: Blue light

Red light

Placebo Comparator group

Description:

The study protocol consisted of two 8-week intervention/control periods in which each participant wore either the intervention (blue light) or control (red light) mask every night, with the order of presentation of the two conditions randomized by the study's biostatistician. A light mask housing two red Light Emitting Diodes (LED) arrays delivered a train of blue or red light pulses of 2 second duration that were presented every 30 s for no longer than 2 hr, resulting in a maximum total of approximately 240 pulses per night. the red light mask was worn nightly for 8 weeks, with a two week washout period between each intervention

Treatment:

Other: Red light