Clinical trial NCT05039749: Human Centric Lighting to Improve Patient Sleep Parameters
Official title: Human Centric Lighting to Improve Patient Sleep Parameters: A Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Disturbance
Lead sponsor: Landstuhl Regional Medical Center
Sponsor class: FED
Collaborators: name: TriService Nursing Research Program
First posted: 2021-09-10
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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.

Primary outcomes:
measure: Total Sleep Time
timeFrame: During participant's inpatient stay, not to exceed 5 days.
measure: Sleep Efficiency
timeFrame: During participant's inpatient stay, not to exceed 5 days.
measure: Sleep Patterns
timeFrame: During participant's inpatient stay, not to exceed 5 days.
measure: Dim Light Melatonin Onset - collection
timeFrame: During participant's inpatient stay, not to exceed 5 days.
measure: Patient experience
timeFrame: One time - approximately a 5 to 15 minute interview
Secondary outcomes:
measure: Dim Light Melatonin Onset - analysis
timeFrame: Collected during participant's inpatient stay, not to exceed 5 days.
Other outcomes:
Locations:
city: Landstuhl
country: Germany
facility: Landstuhl Regional Medical Center
Study officials:
affiliation: US Army Landstuhl Regional Medical Ceneter
name: Pauline A Swiger, PhD
role: PRINCIPAL_INVESTIGATOR
References: