Clinical trial NCT06802367: Hospital Environmental Exposure
Official title: Environmental Exposures in a Clinical Setting: the Impact on Patients
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Environment
Sleep
Noise Exposure
Air Quality
Light
Keywords: Air quality
Noise
Light
Sleep
Lead sponsor: University of Leicester
Sponsor class: OTHER
Collaborators: name: University Hospitals, Leicester
First posted: 2025-01-31
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: University Hospitals Leicester Patients

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Concentrations of nitrogen dioxide (NO2) in selected hospital wards
timeFrame: From the start of the data collection period to June 2026, an average of 1 year, 6 months
measure: Comparisons of NO2 concentrations measured in selected hospital wards with published guidelines
timeFrame: From the start of the data collection period to June 2026, an average of 1 year, 6 months
measure: Concentrations of ozone (O3) in selected hospital wards
timeFrame: From the start of the data collection period to June 2026, an average of 1 year, 6 months
measure: Concentrations of particulate matter (PM2.5) in selected hospital wards
timeFrame: Through study completion, an average of 1 year, 11 months
measure: Comparisons of PM2.5 concentrations measured in selected hospital wards with published guidelines
timeFrame: From the start of the data collection period to June 2026, an average of 1 year, 6 months
measure: Measurements of noise volume in selected hospital wards
timeFrame: From the start of the data collection period to June 2026, an average of 1 year, 6 months
measure: Comparisons of measured volume in selected hospital wards with published guidelines
timeFrame: From the start of the data collection period to June 2026, an average of 1 year, 6 months
measure: Measurements of noise frequency in selected hospital wards
timeFrame: From the start of the data collection period to June 2026, an average of 1 year, 6 months
measure: The temperature in selected hospital wards will be measured.
timeFrame: From the start of the data collection period to June 2026, an average of 1 year, 6 months
measure: Light illuminance measured in selected wards
timeFrame: From the start of the data collection period to June 2026, an average of 1 year, 6 months
measure: Total sleep time
timeFrame: Up to 7 days from the date of recruitment or until the participant moves ward or is discharged (whichever is first)
measure: Sleep Onset Latency
timeFrame: Up to 7 days from the date of recruitment or until the participant moves ward or is discharged (whichever is first)
measure: Sleep Efficiency (%)
timeFrame: Up to 7 days from the date of recruitment or until the participant moves ward or is discharged (whichever is first)
measure: Wake after sleep onset
timeFrame: Up to 7 days from the date of recruitment or until the participant moves ward or is discharged (whichever is first)
measure: Number of awakenings
timeFrame: Up to 7 days from the date of recruitment or until the participant moves ward or is discharged (whichever is first)
measure: Number of naps
timeFrame: Up to 7 days from the date of recruitment or until the participant moves ward or is discharged (whichever is first)
measure: Score on a Sleep Diary
timeFrame: Every morning for up to 7 days from the date of recruitment or until the participant moves ward or is discharged (whichever is first)
measure: Sleep Diary
timeFrame: Every morning for up to 7 days from the date of recruitment or until the participant moves ward or is discharged (whichever is first)
measure: Sleep Diary
timeFrame: From the date of recruitment or until the participant moves ward or is discharged (whichever is first)
measure: Score on a Sleep Diary
timeFrame: From the date of recruitment or until the participant moves ward or is discharged (whichever is first)
measure: Sleep Diary- sleep at home
timeFrame: From the date of recruitment or until the participant moves ward or is discharged (whichever is first)
Secondary outcomes:
measure: Suggested interventions which could be used to improve the patient's environment within the hospital.
timeFrame: Through study completion, an average of 1 year, 11 months
Other outcomes:
Locations:
Study officials:
affiliation: University of Leicester
name: Joshua Vande Hey, PhD
role: STUDY_CHAIR
affiliation: University Hospitals, Leicester
name: Antonella Ghezzi
role: PRINCIPAL_INVESTIGATOR
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