Back to resultsHuman Centric Lighting to Improve Patient Sleep Parameters
Primary Purpose
Sleep Disturbance
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Human Centric Lights
Sponsored by
About this trial
This is an interventional other trial for Sleep Disturbance
Eligibility Criteria
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.
Sites / Locations
- Landstuhl Regional Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Human Central Lighting (HCL) Room
Standard Hospital Lighting (SL) Room
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Total Sleep Time
Assess the feasibility of measuring total sleep time in MS setting, using an actigraphy device.
Sleep Efficiency
Assess the feasibility of measuring sleep efficiency in MS setting, using an actigraphy device.
Sleep Patterns
Assess the feasibility of assessing sleep patterns in MS setting, using a Consensus Sleep Diary (CSD).
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.
Patient experience
Describe the patient's experience of participating in the study, in a MS setting, using a semi-structured interview (SSI).
Secondary Outcome Measures
Dim Light Melatonin Onset - analysis
Conduct a preliminary evaluation of the effect of light on inpatient sleep using dim light melatonin onset saliva sampling.
Full Information
NCT ID
NCT05039749
First Posted
June 25, 2021
Last Updated
September 3, 2021
Sponsor
Landstuhl Regional Medical Center
Collaborators
TriService Nursing Research Program
1. Study Identification
Unique Protocol Identification Number
NCT05039749
Brief Title
Human Centric Lighting to Improve Patient Sleep Parameters
Official Title
Human Centric Lighting to Improve Patient Sleep Parameters: A Feasibility Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
November 1, 2020 (Actual)
Primary Completion Date
April 30, 2021 (Actual)
Study Completion Date
May 15, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Landstuhl Regional Medical Center
Collaborators
TriService Nursing Research Program
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Disturbance
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Human Central Lighting (HCL) Room
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard Hospital Lighting (SL) Room
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Human Centric Lights
Intervention Description
Bright light is emitted during the day from 06:00, then auto-dimmed light is used at night, beginning 19:00.
Primary Outcome Measure Information:
Title
Total Sleep Time
Description
Assess the feasibility of measuring total sleep time in MS setting, using an actigraphy device.
Time Frame
During participant's inpatient stay, not to exceed 5 days.
Title
Sleep Efficiency
Description
Assess the feasibility of measuring sleep efficiency in MS setting, using an actigraphy device.
Time Frame
During participant's inpatient stay, not to exceed 5 days.
Title
Sleep Patterns
Description
Assess the feasibility of assessing sleep patterns in MS setting, using a Consensus Sleep Diary (CSD).
Time Frame
During participant's inpatient stay, not to exceed 5 days.
Title
Dim Light Melatonin Onset - collection
Description
Assess the feasibility of collecting samples to assess dim light melatonin onset in MS setting, using passive drool saliva sampling.
Time Frame
During participant's inpatient stay, not to exceed 5 days.
Title
Patient experience
Description
Describe the patient's experience of participating in the study, in a MS setting, using a semi-structured interview (SSI).
Time Frame
One time - approximately a 5 to 15 minute interview
Secondary Outcome Measure Information:
Title
Dim Light Melatonin Onset - analysis
Description
Conduct a preliminary evaluation of the effect of light on inpatient sleep using dim light melatonin onset saliva sampling.
Time Frame
Collected during participant's inpatient stay, not to exceed 5 days.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pauline A Swiger, PhD
Organizational Affiliation
US Army Landstuhl Regional Medical Ceneter
Official's Role
Principal Investigator
Facility Information:
Facility Name
Landstuhl Regional Medical Center
City
Landstuhl
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
No
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Human Centric Lighting to Improve Patient Sleep Parameters
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