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Completed

NCT Number: NCT01855126

Individually Tailored Lighting System to Improve Sleep in Older Adults

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

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Key information

Conditions

Sleep Disturbances Mental Disorders Nervous System Diseases Parasomnias Sleep Wake Disorders

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rensselaer Polytechnic Institute

Troy, New York, 12180, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blue Light

Other

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

Other

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.

Primary outcomes

  1. Sleep Disturbance

    Time frame: Baseline (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.

  2. Total Sleep Time

    Time frame: baseline 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

  3. Sleep Efficiency

    Time frame: baseline 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.

  4. Sleep Start Time

    Time frame: baseline 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

Sponsors and collaborators

Lead sponsor

Rensselaer Polytechnic Institute

Other

Collaborators

  • University of North Carolina

Registry information

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
May 16, 2013
Registry last updated
Jan 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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