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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05039749
Other study ID # LRMC CY16-36
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 1, 2020
Est. completion date May 15, 2021

Study information

Verified date September 2021
Source Landstuhl Regional Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 13
Est. completion date May 15, 2021
Est. primary completion date April 30, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Germany Landstuhl Regional Medical Center Landstuhl

Sponsors (2)

Lead Sponsor Collaborator
Landstuhl Regional Medical Center TriService Nursing Research Program

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
Primary 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.
Primary 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.
Primary 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.
Primary 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 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.
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