Sleep DisturbanceNCT05039749
Human Centric Lighting to Improve Patient Sleep Parameters
A study testing Human Centric Lights in people with Sleep Disturbance, run by Landstuhl Regional Medical Center at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sleep Disturbance
- What is being tested?
- Human Centric Lights
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteGermany
- Study dates
- 1 Nov 2020to 15 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Human Centric Lighting to Improve Patient Sleep Parameters: A Feasibility Study
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
- Being tested
- Human Centric Lights
- Medical subject headings
- Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human Centric LightsDevice
Bright light is emitted during the day from 06:00, then auto-dimmed light is used at night, beginning 19:00.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Sleep Time
Assess the feasibility of measuring total sleep time in MS setting, using an actigraphy device.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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).
Measured: One time - approximately a 5 to 15 minute interview
Secondary outcomes (1)
Dim Light Melatonin Onset - analysis
Conduct a preliminary evaluation of the effect of light on inpatient sleep using dim light melatonin onset saliva sampling.
Measured: Collected during participant's inpatient stay, not to exceed 5 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2021
- Study start1 Nov 2020
- Primary completion30 Apr 2021
- Study completion15 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DisturbanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Landstuhl Regional Medical Center
- Sponsor type
- US federal agency
- Collaborators
- TriService Nursing Research Program
- Responsible party
- Principal investigator, LTC Pauline Swiger, Landstuhl Regional Medical Center
- Investigators
- Pauline A Swiger, PhD, Principal investigator, US Army Landstuhl Regional Medical Ceneter
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05039749
- Sponsor's protocol ID
- LRMC CY16-36
- Status last verified
- Sep 2021
- First submitted
- 25 Jun 2021
- Last updated
- 10 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Human Centric Lighting to Improve Patient Sleep Parameters: A Feasibility Study
- ClinicalTrials.gov ID
- NCT05039749
- Acronym / sponsor ID
- LRMC CY16-36
- Conditions
- Sleep Disturbance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Landstuhl Regional Medical CenterUS federal agency
- Collaborators
- TriService Nursing Research Program
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 15 May 2021 (actual)
- First posted
- 10 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Human Central Lighting (HCL) Room | Experimental | Device: Human Centric LightsThis 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Human Centric LightsBright light is emitted during the day from 06:00, then auto-dimmed light is used at night, beginning 19:00. | Device | Human Central Lighting (HCL) Room |
Primary outcome
Total Sleep Time
Time frame: During participant's inpatient stay, not to exceed 5 days.
Assess the feasibility of measuring total sleep time in MS setting, using an actigraphy device.
Sleep Efficiency
Time frame: During participant's inpatient stay, not to exceed 5 days.
Assess the feasibility of measuring sleep efficiency in MS setting, using an actigraphy device.
Sleep Patterns
Time frame: During participant's inpatient stay, not to exceed 5 days.
Assess the feasibility of assessing sleep patterns in MS setting, using a Consensus Sleep Diary (CSD).
Dim Light Melatonin Onset - collection
Time frame: During participant's inpatient stay, not to exceed 5 days.
Assess the feasibility of collecting samples to assess dim light melatonin onset in MS setting, using passive drool saliva sampling.
Patient experience
Time frame: One time - approximately a 5 to 15 minute interview
Describe the patient's experience of participating in the study, in a MS setting, using a semi-structured interview (SSI).
1 secondary outcome
Dim Light Melatonin Onset - analysis
Time frame: Collected during participant's inpatient stay, not to exceed 5 days.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pauline A Swiger, PhD principal investigator
US Army Landstuhl Regional Medical Ceneter
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Human Centric Lights in people with Sleep Disturbance, run by Landstuhl Regional Medical Center at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Sleep Time (time frame: During participant's inpatient stay, not to exceed 5 days.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2021.