Human Centric Lighting to Improve Patient Sleep Parameters

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

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.

Study Overview

• Status: Completed
• Conditions: Sleep Disturbance
• Intervention / Treatment: Device: Human Centric Lights

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Landstuhl, Germany
    • Landstuhl Regional Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Human Central Lighting (HCL) Room; 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; Bright light is emitted during the day from 06:00, then auto-dimmed light is used at night, beginning 19:00.
No Intervention: Standard Hospital Lighting (SL) Room; 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?

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.

Collaborators and Investigators

• Sponsor: Landstuhl Regional Medical Center
• Collaborators: TriService Nursing Research Program
• Investigators: Principal Investigator: Pauline A Swiger, PhD, US Army Landstuhl Regional Medical Ceneter

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2020
• Primary Completion (Actual): April 30, 2021
• Study Completion (Actual): May 15, 2021

Study Registration Dates

• First Submitted: June 25, 2021
• First Submitted That Met QC Criteria: September 3, 2021
• First Posted (Actual): September 10, 2021

Study Record Updates

• Last Update Posted (Actual): September 10, 2021
• Last Update Submitted That Met QC Criteria: September 3, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Wake Disorders; Dyssomnias; Parasomnias
• Other Study ID Numbers: LRMC CY16-36

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No