Individually Tailored Lighting System to Improve Sleep in Older Adults
Phase: NA
Conditions: Sleep Disturbances
Sponsor: Rensselaer Polytechnic Institute

 
 
 
 
Individually Tailored Lighting System to Improve Sleep in Older Adults 
NCT01855126 
November 5, 2018 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Study Protocol 
 
The study will be a randomized trial in 50 community-dwelling older adults with early 
awakening insomnia who live at home, using a within-subject crossover design. The control 
condition will be a red light mask; the intervention will be a blue light mask (individualized to 
the patient’s light exposure and circadian rhythm).  Subjects will use each condition for eight 
weeks, with the intervention order counterbalanced across subjects, a two-week baseline 
observation period, and a two-week washout period between the two study conditions.  
Outcomes will be assessed at baseline and 8 weeks for all measures except for (a) side effects, 
adverse effects, and protocol deviations, which will be monitored weekly, and (b) clinical eye 
examinations, which will be conducted at baseline and at the end of each study condition.