Human Centric Lighting to Improve Patient Sleep Parameters

Study Overview
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Brief Summary
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Human centric lighting (HCL) is a technology that supports the body's circadian rhythm, as it can stimulate the sleep triggering hormone, melatonin, to improve sleep hygiene over standard lighting (SL), and promote recuperative sleep for a timely return-to-duty. In intensive care units, exposure to HCL has improved sleep measures. However, the effect in the medical surgical (MS) environment is unknown. The purpose of this study is to assess the feasibility of study procedures in MS setting and conduct a preliminary evaluation of the effect of light on inpatient sleep. Recruitment started November 2020 through April 2021. Data analysis is pending.

Official Title
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Human Centric Lighting to Improve Patient Sleep Parameters: A Feasibility Study

Conditions
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Sleep Disturbance

Intervention / Treatment
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* Device: Human Centric Lights


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient who is an active duty service member, GS Civilian, Dependent or Retiree affiliated with the Army, Air Force or Navy. Patient who is informed by provider or anticipates being admitted for at least two nights. Patient who can read and speak English fluently (since surveys are not translated in any other language). Exclusion Criteria: Patient with visual impairment which cannot be corrected with glasses or contact lenses such as complete blindness, (defined as inability to see light), or partial blindness (defined as very limited vision) such as patients with history of cataracts. Patient taking an oral medication for sleep. Patient receiving radioactive ionization treatment. Patient who requires isolation or palliative care. Patient recovering from head/neck or oral maxillofacial surgery that would impede saliva sample collection (i.e. jaw wiring, extensive gauze packing in oral cavity) Patient who reports status as a Department of Defense Contractor at screening.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Human Central Lighting (HCL) Room<br>This inpatient room was outfitted with lights that mimic the day/night cycle, thereby supporting circadian rhythm. Day time lights were automatically on during 0600 to 1900 and in use any time the patients would normally utilize their lights, with a goal of three hours of light exposure per day. The lights automatically transitioned to warmer toned evening lighting at 1900. | Device: Human Centric Lights<br>* Bright light is emitted during the day from 06:00, then auto-dimmed light is used at night, beginning 19:00.<br>|
| No Intervention: Standard Hospital Lighting (SL) Room<br>The lighting in this room was standard florescent hospital lighting. The only changes in the lighting was the on/off settings normally associated with lighting. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Sleep Time | Assess the feasibility of measuring total sleep time in MS setting, using an actigraphy device. | During participant's inpatient stay, not to exceed 5 days. | 
| Sleep Efficiency | Assess the feasibility of measuring sleep efficiency in MS setting, using an actigraphy device. | During participant's inpatient stay, not to exceed 5 days. | 
| Sleep Patterns | Assess the feasibility of assessing sleep patterns in MS setting, using a Consensus Sleep Diary (CSD). | During participant's inpatient stay, not to exceed 5 days. | 
| Dim Light Melatonin Onset - collection | Assess the feasibility of collecting samples to assess dim light melatonin onset in MS setting, using passive drool saliva sampling. | During participant's inpatient stay, not to exceed 5 days. | 
| Patient experience | Describe the patient's experience of participating in the study, in a MS setting, using a semi-structured interview (SSI). | One time - approximately a 5 to 15 minute interview | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dim Light Melatonin Onset - analysis | Conduct a preliminary evaluation of the effect of light on inpatient sleep using dim light melatonin onset saliva sampling. | Collected during participant's inpatient stay, not to exceed 5 days. |