Human Centric Lighting to Improve Patient Sleep Parameters

NCT ID: NCT05039749

Last Updated: 2021-09-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-01
• Study Completion Date: 2021-05-15

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Human Central Lighting (HCL) Room

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.

Group Type: EXPERIMENTAL

Human Centric Lights

Intervention Type: DEVICE

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

Standard Hospital Lighting (SL) Room

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Human Centric Lights

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

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

TriService Nursing Research Program

OTHER

Sponsor Role: collaborator

Landstuhl Regional Medical Center

FED

Sponsor Role: lead

Responsible Party

LTC Pauline Swiger

On-Site Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Pauline A Swiger, PhD

Role: PRINCIPAL_INVESTIGATOR

US Army Landstuhl Regional Medical Ceneter

Locations

Landstuhl Regional Medical Center

Landstuhl, , Germany

Countries

Germany

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

LRMC CY16-36

Identifier Type: -

Identifier Source: org_study_id