Human Centric Lighting to Improve Patient Sleep Parameters

Sleep Disturbance Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05039749
• Other study ID #: LRMC CY16-36
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Dyssomnias
• Parasomnias
• Sleep Disturbance

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.