Hospital Environmental Exposure

NCT06802367 | Not Yet Recruiting

• 1 other identifier: 0988
• Study Type: observational
• Target: 120
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Environment; Sleep; Noise Exposure; Air Quality; Light

Keywords

Air quality; Noise; Light; Sleep

Outcome Measures

Primary Outcomes (21)

• Concentrations of nitrogen dioxide (NO2) in selected hospital wards

  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

  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

  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

  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

  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

  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

  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

  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.

  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

  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

  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

  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 (%)

  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

  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

  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

  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

  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

  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

  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

  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

  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 Outcomes (1)

• Suggested interventions which could be used to improve the patient's environment within the hospital.

  Through study completion, an average of 1 year, 11 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

University Hospitals Leicester Patients

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Leicester: lead
• University Hospitals, Leicester: collaborator

Related Publications (16)

• Fonseca A, Abreu I, Guerreiro MJ, Barros N. Indoor Air Quality in Healthcare Units- A Systematic Literature Review Focusing Recent Research. Sustainability. 2022;14(2)

  BACKGROUND

• Berglund B, Lindvall T, Schwela DH. New WHO guidelines for community noise. Noise & Vibration Worldwide. 2000;31(4):24-29

  BACKGROUND

• Emar M, Smith E, Coats TJ. Background noise in an Emergency Department: an observational study from staff and patient perspectives. medRxiv. 2022:2022.2005.2020.22275148

  BACKGROUND

• Hillman DR. Sleep Loss in the Hospitalized Patient and Its Influence on Recovery From Illness and Operation. Anesth Analg. 2021 May 1;132(5):1314-1320. doi: 10.1213/ANE.0000000000005323.

  PMID: 33857973 BACKGROUND

• Luyster FS, Strollo PJ Jr, Zee PC, Walsh JK; Boards of Directors of the American Academy of Sleep Medicine and the Sleep Research Society. Sleep: a health imperative. Sleep. 2012 Jun 1;35(6):727-34. doi: 10.5665/sleep.1846.

  PMID: 22654183 BACKGROUND

• Lucchini A, Giani M, Ferrari K, Di Maria S, Galimberti G, Zorz A, Iozzo P, Elli S, Fumagalli R, Bambi S. Sound and Light Levels in a General Intensive Care Unit Without Windows to Provide Natural Light. Dimens Crit Care Nurs. 2023 Mar-Apr 01;42(2):115-123. doi: 10.1097/DCC.0000000000000569.

  PMID: 36720036 BACKGROUND

• Xie H, Kang J, Mills GH. Clinical review: The impact of noise on patients' sleep and the effectiveness of noise reduction strategies in intensive care units. Crit Care. 2009;13(2):208. doi: 10.1186/cc7154. Epub 2009 Mar 9.

  PMID: 19344486 BACKGROUND

• Touitou Y, Reinberg A, Touitou D. Association between light at night, melatonin secretion, sleep deprivation, and the internal clock: Health impacts and mechanisms of circadian disruption. Life Sci. 2017 Mar 15;173:94-106. doi: 10.1016/j.lfs.2017.02.008. Epub 2017 Feb 16.

  PMID: 28214594 BACKGROUND

• Boivin DB, Duffy JF, Kronauer RE, Czeisler CA. Dose-response relationships for resetting of human circadian clock by light. Nature. 1996 Feb 8;379(6565):540-2. doi: 10.1038/379540a0.

  PMID: 8596632 BACKGROUND

• Elbaz M, Leger D, Sauvet F, Champigneulle B, Rio S, Strauss M, Chennaoui M, Guilleminault C, Mira JP. Sound level intensity severely disrupts sleep in ventilated ICU patients throughout a 24-h period: a preliminary 24-h study of sleep stages and associated sound levels. Ann Intensive Care. 2017 Dec;7(1):25. doi: 10.1186/s13613-017-0248-7. Epub 2017 Mar 3.

  PMID: 28255956 BACKGROUND

• Sanchez T, Gozal D, Smith DL, Foncea C, Betancur C, Brockmann PE. Association between air pollution and sleep disordered breathing in children. Pediatr Pulmonol. 2019 May;54(5):544-550. doi: 10.1002/ppul.24256. Epub 2019 Feb 4.

  PMID: 30719878 BACKGROUND

• Tsai LJ, Yuan TH, Shie RH, Chiang CH, Chan CC. Association between ambient air pollution exposure and insomnia among adults in Taipei City. Sci Rep. 2022 Nov 9;12(1):19064. doi: 10.1038/s41598-022-21964-0.

  PMID: 36351973 BACKGROUND

• Oliveira L, Gomes C, Bacelar Nicolau L, Ferreira L, Ferreira R. Environment in pediatric wards: light, sound, and temperature. Sleep Med. 2015 Sep;16(9):1041-8. doi: 10.1016/j.sleep.2015.03.015. Epub 2015 Apr 27.

  PMID: 26298777 BACKGROUND

• Cincinelli A, Martellini T. Indoor Air Quality and Health. Int J Environ Res Public Health. 2017 Oct 25;14(11):1286. doi: 10.3390/ijerph14111286.

  PMID: 29068361 BACKGROUND

• Stansfeld SA, Matheson MP. Noise pollution: non-auditory effects on health. Br Med Bull. 2003;68:243-57. doi: 10.1093/bmb/ldg033.

  PMID: 14757721 BACKGROUND

• GBD 2017 Risk Factor Collaborators. Global, regional, and national comparative risk assessment of 84 behavioural, environmental and occupational, and metabolic risks or clusters of risks for 195 countries and territories, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet. 2018 Nov 10;392(10159):1923-1994. doi: 10.1016/S0140-6736(18)32225-6. Epub 2018 Nov 8.

  PMID: 30496105 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Environmental data collected (noise, light and air quality levels). Body temperature, heart rate and measurements of patient sleep using wearable sensors.

Study Officials

• Joshua Vande Hey, PhD

  University of Leicester

  STUDY CHAIR

• Antonella Ghezzi

  University Hospitals, Leicester

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rikesh Panchal, PhD

CONTACT

+44(0)116 229 7659; rp173@leicester.ac.uk

Sarah Johnson, PhD

CONTACT

sj239@leicester.ac.uk

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2024
• First Posted: January 31, 2025
• Study Start: January 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 31, 2025

Record last verified: 2025-01