Human Centric Lighting to Improve Patient Sleep Parameters

NCT05039749 | Completed

• 1 other identifier: LRMC CY16-36
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Disturbance

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (1)

• Dim Light Melatonin Onset - analysis

  Collected during participant's inpatient stay, not to exceed 5 days.

Study Arms (2)

Human Central Lighting (HCL) Room

EXPERIMENTAL

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

Standard Hospital Lighting (SL) Room

NO INTERVENTION

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.

Interventions

Human Centric Lights DEVICE

Bright light is emitted during the day from 06:00, then auto-dimmed light is used at night, beginning 19:00.

Human Central Lighting (HCL) Room

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Landstuhl Regional Medical Center: lead
• TriService Nursing Research Program: collaborator

Study Sites (1)

Landstuhl Regional Medical Center

Landstuhl, Germany

Location

MeSH Terms

Conditions

Parasomnias

Condition Hierarchy (Ancestors)

Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Pauline A Swiger, PhD

  US Army Landstuhl Regional Medical Ceneter

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: On-Site Principal Investigator

Study Record Dates

• First Submitted: June 25, 2021
• First Posted: September 10, 2021
• Study Start: November 1, 2020
• Primary Completion: April 30, 2021
• Study Completion: May 15, 2021
• Last Updated: September 10, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)