Hospital Environmental Exposure

January 24, 2025 updated by: University of Leicester

Environmental Exposures in a Clinical Setting: the Impact on Patients

There is an increasing body of evidence that human health is affected by environmental factors such as air quality, noise and light. This applies to both indoor and outdoor environments. While there have been several studies looking at homes, offices and work environments, hospital environments are still poorly characterised. Indoor hospital environments are complex, and patients with various health conditions can spend extended periods of time in wards. A number of studies have reported an association of air pollution exposure and a disturbance to sleep. A lack of sleep, or poor and disrupted sleep can impact health. Disturbed sleep therefore can impact a patient's recovery in hospital wards. In addition to the exposure to air pollutants, noise and light levels within the hospital environment can also have an impact on patient health. Inadequate, or a disrupted light and dark cycles can impact the circadian rhythm of the human body, responsible for the sleep cycle. In this study, the investigators aim to characterise these exposures and address the impact of these exposures on the patient sleep. Given the links between sleep and the environmental conditions.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

The proposed study will aim to answer the research question- Can a method be developed to assess the impact of environmental exposures on patient sleep in a clinical setting?

There are very few health-based guidelines regarding hospital indoor environments. With regards to noise in hospital wards, the World Health Organisation (WHO) have recommended that noise in hospital wards should not exceed 30 dB at night, however owing to excessive noise generated by a number of factors, these noise levels can be larger, up to 75 dB within intensive care units and 45 dB in emergency departments. Noise therefore is a common complaint from patients with regards to disrupting their sleep. There are also no clear guidelines on light levels in clinical settings. The link between sleep and health is well known. Sleep is not just a period of inactivity or unconsciousness but is a complex physiological process composed of repeated cycles of non-rapid eye movement (NREM) and rapid eye movement (REM). A lack of, or poor sleep can disturb a patients circadian rhythm, changing body temperature (where core temperature changes with sleep- wake cycles), and changing heart rate. In a hospital ward, there are a number of environmental factors that can disturb a patient's sleep. It is therefore important to assess the contributors to poor sleep in a clinical environment and mitigate the adverse effects of poor air quality, light and noise to improve patient sleep. The aim with this work is therefore two-fold. The investigators aim to collect pilot data that quantitatively characterises the indoor environment within a clinical setting in terms of air quality, noise and light. The approach will use, sound level meters, air quality sensors and light level meters installed within a hospital ward to characterise the hospital environment that patients experience. Such techniques provide a meaningful description of the clinical environmental conditions. The data collected will be compared against any available health guidelines. A further aim to assess the impact of these environmental conditions on patient sleep as adequate sleep is essential to health.

To assess the patients, the investigators will be using actigraphy (accelerometer worn on the wrist or arm) activity monitors for sleep monitoring. The participant will also be given a second wearable monitor that will measure their heart rate and body temperature. The data collected from the two wearable monitors will be compared with environmental monitoring data (air quality, light and noise) in order to determine if environmental conditions are linked to sleep patterns. Sleep times, sleep efficiency, number of awakenings and sleep latency will be recorded from the sleep data. The participant will also be given a sleep diary will be used in order to assess the perceived quality of sleep. The sleep diary will be completed during the participants time in the ward and will ask the participant to note, sleep and awake times as well as any sources of disturbing light and noise within the ward in the participants opinion.

Study Type

Observational

Enrollment (Estimated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

University Hospitals Leicester Patients

Description

Inclusion Criteria:

  • Hospital admission with a diagnosis that requires at least 2 nights.
  • Participant is willing and able to give informed consent for participation in the study. If a patient for example has dementia and/ or the inability to retain information or if they are unable to wear the device, they will not be consented.
  • Aged 18 years or above.
  • Able (in the ward staff, research team and investigator's opinion) and willing to comply with all study requirements.

Exclusion Criteria:

  • Any significant disease or disorder which, in the opinion of the investigator, may either put the participants or other patients at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.
  • Reported history of sleep disorders, including obstructive sleep apnoea syndrome (OSAS) or insomnia.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Concentrations of nitrogen dioxide (NO2) in selected hospital wards
Time Frame: From the start of the data collection period to June 2026, an average of 1 year, 6 months
Using air quality sensors installed within selected wards, the concentrations of NO2 (ugm-3) will be measured. Hourly averaged NO2 concentration data will be collected continuously until the end of the data collection period.
From the start of the data collection period to June 2026, an average of 1 year, 6 months
Comparisons of NO2 concentrations measured in selected hospital wards with published guidelines
Time Frame: From the start of the data collection period to June 2026, an average of 1 year, 6 months
Concentrations of NO2 measured within wards will be compared with World Health Organisation (WHO) daily averaged and annual guidelines of NO2 concentrations. Measurements of NO2 will also be compared against UK hourly and annual mean guideline NO2 concentrations.
From the start of the data collection period to June 2026, an average of 1 year, 6 months
Concentrations of ozone (O3) in selected hospital wards
Time Frame: From the start of the data collection period to June 2026, an average of 1 year, 6 months
Using air quality sensors installed within selected wards, the concentrations of O3 (ugm-3). Hourly averaged O3 concentration data will be collected continuously until the end of the data collection period.
From the start of the data collection period to June 2026, an average of 1 year, 6 months
Concentrations of particulate matter (PM2.5) in selected hospital wards
Time Frame: Through study completion, an average of 1 year, 11 months
Using air quality sensors installed within selected wards, the concentrations of PM2.5 (ugm-3). Hourly averaged PM2.5 concentration data will be collected continuously until the end of the data collection period.
Through study completion, an average of 1 year, 11 months
Comparisons of PM2.5 concentrations measured in selected hospital wards with published guidelines
Time Frame: From the start of the data collection period to June 2026, an average of 1 year, 6 months
Concentrations of PM2.5 measured within wards will be compared with World Health Organisation (WHO) daily averaged and annual guidelines of PM2.5 concentrations. Measurements of PM2.5 will also be compared against UK guidelines of annual average PM2.5 concentrations.
From the start of the data collection period to June 2026, an average of 1 year, 6 months
Measurements of noise volume in selected hospital wards
Time Frame: From the start of the data collection period to June 2026, an average of 1 year, 6 months
Portable noise monitors will be installed in selected hospital wards. The noise monitors will measure the volume of noise in wards in decibels (dB) continuously until the end of the data collection period.
From the start of the data collection period to June 2026, an average of 1 year, 6 months
Comparisons of measured volume in selected hospital wards with published guidelines
Time Frame: From the start of the data collection period to June 2026, an average of 1 year, 6 months
WHO have published guidelines of noise levels (in decibels) in hospitals at night and during the day. The measurements of noise collected in this study will be compared with WHO published guidelines.
From the start of the data collection period to June 2026, an average of 1 year, 6 months
Measurements of noise frequency in selected hospital wards
Time Frame: From the start of the data collection period to June 2026, an average of 1 year, 6 months
Portable noise monitors will be installed in selected hospital wards. The noise monitors will measure the frequency of noise in wards (Hz).
From the start of the data collection period to June 2026, an average of 1 year, 6 months
The temperature in selected hospital wards will be measured.
Time Frame: From the start of the data collection period to June 2026, an average of 1 year, 6 months
Using the air quality sensor installed within the ward, the temperature in degrees Celsius (°C) will be measured continuously.
From the start of the data collection period to June 2026, an average of 1 year, 6 months
Light illuminance measured in selected wards
Time Frame: From the start of the data collection period to June 2026, an average of 1 year, 6 months
Portable light level meters will be installed in wards. Illuminance in lux (lx) will be measured continuously.
From the start of the data collection period to June 2026, an average of 1 year, 6 months
Total sleep time
Time Frame: Up to 7 days from the date of recruitment or until the participant moves ward or is discharged (whichever is first)
Measured using actigraphy, total sleep time will be measured (in hours). Measurements will be averaged per day and averaged over the total time the participant was included in the study.
Up to 7 days from the date of recruitment or until the participant moves ward or is discharged (whichever is first)
Sleep Onset Latency
Time Frame: Up to 7 days from the date of recruitment or until the participant moves ward or is discharged (whichever is first)
The time it takes a person to fall asleep after turning the lights off (measured in hours). Measured using actigraphy. Will be averaged per day and averaged over the total time the participant was included in the study.
Up to 7 days from the date of recruitment or until the participant moves ward or is discharged (whichever is first)
Sleep Efficiency (%)
Time Frame: Up to 7 days from the date of recruitment or until the participant moves ward or is discharged (whichever is first)
Sleep Efficiency (%) = (Total Sleep Time (hours)/ Time in Bed (hours)) x 100 Measured using actigraphy. Will be averaged per day and averaged over the total time the participant was included in the study.
Up to 7 days from the date of recruitment or until the participant moves ward or is discharged (whichever is first)
Wake after sleep onset
Time Frame: Up to 7 days from the date of recruitment or until the participant moves ward or is discharged (whichever is first)
Periods of wakefulness after a defined sleep onset. Calculated by the total time of the periods that are inside a sleep period but are not a sleep state (ex.: rest, awake) Measured using actigraphy. Measured in minutes. Will be averaged per day and averaged over the total time the participant was included in the study.
Up to 7 days from the date of recruitment or until the participant moves ward or is discharged (whichever is first)
Number of awakenings
Time Frame: Up to 7 days from the date of recruitment or until the participant moves ward or is discharged (whichever is first)
The number of rest/ awake periods. Measured using actigraphy. Will be averaged per day and averaged over the total time the participant was included in the study.
Up to 7 days from the date of recruitment or until the participant moves ward or is discharged (whichever is first)
Number of naps
Time Frame: Up to 7 days from the date of recruitment or until the participant moves ward or is discharged (whichever is first)
Measured using actigraphy. Will be averaged per day and averaged over the total time the participant was included in the study.
Up to 7 days from the date of recruitment or until the participant moves ward or is discharged (whichever is first)
Score on a Sleep Diary
Time Frame: Every morning for up to 7 days from the date of recruitment or until the participant moves ward or is discharged (whichever is first)

Participants will be asked to complete a sleep diary. The sleep diary will ask the participant to score their:

Mood during the day (1 = lowest mood, 10= excellent mood), Tiredness during the day (1 = least tired, 10= most tired), Activity during the day? (1= least active, 10 = most active), Quality of your sleep in hospital? (1= worst, 10= excellent), On waking up in the morning, how rested do they feel? (1= least rested, 10= most rested), How disruptive was the noise in the ward to their sleep? (1= least disruptive, 10= most disruptive), How disruptive was the light in the ward to their sleep? (1 least disruptive, 10= most disruptive).

This question will be asked every morning for 7 days. These questions will be asked every morning for 7 days.
Every morning for up to 7 days from the date of recruitment or until the participant moves ward or is discharged (whichever is first)
Sleep Diary
Time Frame: Every morning for up to 7 days from the date of recruitment or until the participant moves ward or is discharged (whichever is first)

Participants will be asked to complete a sleep diary. The sleep diary will ask the participant:

How many naps did they take during the day? How long for? Time they went to sleep for the night Number of times they woke up in the night Number of hours they slept last night This question will be asked every morning for 7 days. This question will be asked every morning for 7 days.
Every morning for up to 7 days from the date of recruitment or until the participant moves ward or is discharged (whichever is first)
Sleep Diary
Time Frame: From the date of recruitment or until the participant moves ward or is discharged (whichever is first)

Participants will be asked to complete a sleep diary. The sleep diary will ask the participant, yes/ no questions on:

Have you/are you currently using an eye mask in hospital? Have you/are you currently using an ear plugs in hospital? These questions will only be asked once
From the date of recruitment or until the participant moves ward or is discharged (whichever is first)
Score on a Sleep Diary
Time Frame: From the date of recruitment or until the participant moves ward or is discharged (whichever is first)
Participants will be asked to complete a sleep diary. The sleep diary will ask the participant list and to score any disruptive noises within the hospital ward that impacts their sleep (1 is no disruption and 10 is significant disruption). This question will be asked once.
From the date of recruitment or until the participant moves ward or is discharged (whichever is first)
Sleep Diary- sleep at home
Time Frame: From the date of recruitment or until the participant moves ward or is discharged (whichever is first)

Participants will be asked to complete a sleep diary. The sleep diary will also ask questions regarding their sleep at home:

What time do you usually go to sleep at home? What time do you usually wake up in the mornings at home? On average, at home, how many hours a night do you usually sleep? Rate the quality of your usual sleep at home. (1= worst, 10= excellent). Yes/ No questions will also be asked regarding the participant wearing an eye mask and ear plugs at home.

Space is also provided for the participant to add additional notes These questions will be asked once.
From the date of recruitment or until the participant moves ward or is discharged (whichever is first)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Suggested interventions which could be used to improve the patient's environment within the hospital.
Time Frame: Through study completion, an average of 1 year, 11 months
The patient will be asked to complete a sleep diary. The sleep diary will also ask the patient to list any environmental conditions (light or noise) that disturbs their sleep. This data will be used to suggest methods that can be used to improve the light and noise levels within that specific ward.
Through study completion, an average of 1 year, 11 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Leicester

Collaborators

University Hospitals, Leicester

Investigators

  • Study Chair: Joshua Vande Hey, PhD, University of Leicester
  • Principal Investigator: Antonella Ghezzi, University Hospitals, Leicester

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

December 10, 2024

First Submitted That Met QC Criteria

January 24, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 24, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 0988

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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