Hospital Environmental Exposure

NCT ID: NCT06802367

Last Updated: 2025-01-31

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 120 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-01-31
• Study Completion Date: 2026-12-31

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.

Conditions

Environment; Sleep; Noise Exposure; Air Quality; Light

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospitals, Leicester

OTHER

Sponsor Role: collaborator

University of Leicester

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joshua Vande Hey, PhD

Role: STUDY_CHAIR

University of Leicester

Antonella Ghezzi

Role: PRINCIPAL_INVESTIGATOR

University Hospitals, Leicester

Central Contacts

Rikesh Panchal, PhD

Role: CONTACT

rp173@leicester.ac.uk

+44(0)116 229 7659

Sarah Johnson, PhD

Role: CONTACT

sj239@leicester.ac.uk

References

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)

Reference Type: BACKGROUND

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

Reference Type: 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

Reference Type: 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.

Reference Type: BACKGROUND

PMID: 33857973 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22654183 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 36720036 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19344486 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28214594 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 8596632 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28255956 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30719878 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 36351973 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26298777 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29068361 (View on PubMed)

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

Reference Type: BACKGROUND

PMID: 14757721 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30496105 (View on PubMed)

Other Identifiers

0988

Identifier Type: -

Identifier Source: org_study_id