EnvironmentNCT06802367
Hospital Environmental Exposure
An observational study of Environment and Sleep, run by University of Leicester at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Environment, Sleep, Noise Exposure
- How many people
- 120 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 8 Apr 2025to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Adult, Older adult
Study population: University Hospitals Leicester Patients
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sarah Johnson, PhD contact
United Kingdom1 site, 1 recruiting
- Recruiting
Glenfield Hospital
Leicester, Leicester, LE3 9QP
Hamish McAuley, PhD, +44 0116 258 3370, hjcm1@leicester.ac.uk
About this study
Official title: 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.
Read the 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
- Keywords
- Air quality, Noise, Light, Sleep
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
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.
Measured: Through study completion, an average of 1 year, 11 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2025
- Study start8 Apr 2025
- Primary completionJun 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for EnvironmentStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Leicester
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospitals, Leicester
- Responsible party
- Sponsor
- Investigators
- Joshua Vande Hey, PhD, Study chair, University of LeicesterAntonella Ghezzi, Principal investigator, University Hospitals, Leicester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06802367
- Sponsor's protocol ID
- 0988
- Status last verified
- Sep 2025
- First submitted
- 10 Dec 2024
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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)
Berglund B, Lindvall T, Schwela DH. New WHO guidelines for community noise. Noise & Vibration Worldwide. 2000;31(4):24-29
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
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.
PubMed 33857973Luyster 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.
PubMed 22654183Lucchini 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.
PubMed 36720036Xie 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.
PubMed 19344486Touitou 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.
PubMed 28214594Boivin DB, Duffy JF, Kronauer RE, Czeisler CA; New Collective Author. Dose-response relationships for resetting of human circadian clock by light. Nature. 1996 Feb 8;379(6565):540-2. doi: 10.1038/379540a0.
PubMed 8596632Elbaz 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.
PubMed 28255956Sanchez 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.
PubMed 30719878Tsai 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.
PubMed 36351973Oliveira 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.
PubMed 26298777Cincinelli A, Martellini T. Indoor Air Quality and Health. Int J Environ Res Public Health. 2017 Oct 25;14(11):1286. doi: 10.3390/ijerph14111286.
PubMed 29068361Stansfeld SA, Matheson MP. Noise pollution: non-auditory effects on health. Br Med Bull. 2003;68:243-57. doi: 10.1093/bmb/ldg033.
PubMed 14757721
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Environmental Exposures in a Clinical Setting: the Impact on Patients
- ClinicalTrials.gov ID
- NCT06802367
- Acronym / sponsor ID
- 0988
- Conditions
- Environment, Sleep, Noise Exposure, Air Quality, Light
- Keywords
- Air quality, Noise, Light, Sleep
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of LeicesterUniversity, hospital or other
- Collaborators
- University Hospitals, Leicester
- Study start
- 8 Apr 2025 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 31 Jan 2025 (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.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- University Hospitals Leicester Patients
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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).
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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
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.
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.
1 secondary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
- BackgroundFonseca A, Abreu I, Guerreiro MJ, Barros N. Indoor Air Quality in Healthcare Units- A Systematic Literature Review Focusing Recent Research. Sustainability. 2022;14(2)
- BackgroundBerglund B, Lindvall T, Schwela DH. New WHO guidelines for community noise. Noise & Vibration Worldwide. 2000;31(4):24-29
- BackgroundEmar 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: PubMed 33857973Hillman 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.
- Background: PubMed 22654183Luyster 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.
- Background: PubMed 36720036Lucchini 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.
- Background: PubMed 19344486Xie 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.
- Background: PubMed 28214594Touitou 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.
- Background: PubMed 8596632Boivin DB, Duffy JF, Kronauer RE, Czeisler CA; New Collective Author. Dose-response relationships for resetting of human circadian clock by light. Nature. 1996 Feb 8;379(6565):540-2. doi: 10.1038/379540a0.
- Background: PubMed 28255956Elbaz 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.
- Background: PubMed 30719878Sanchez 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.
- Background: PubMed 36351973Tsai 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.
Related trials for Environment
Recruiting
Lungs on Fire: Wildfire Smoke, Incident Diseases, Susceptible Populations, and Community Values in Canada
Asthma, Chronic Obstructive Pulmonary Disease (COPD)
Recruiting
Cycling Within an Interactive and Immersive Virtual Environment During Critical Illness: a Patient-centred Approach for Lower Limb Rehabilitation
Critical Illness
Recruiting
Ambient Air and Noise Effect on Cardiovascular Health Risk and Lifestyle Intervention to Attenuate It (METSGREEN)
Cardiovascular Diseases (CVD), Metabolic Syndrome
Not yet recruitingObservational study
A Natural History of Genetic and Environmental Predictors of Pubertal Timing Among Youth With Obesity
Obesity
RecruitingPhase 1
Environment and Alcohol: A Pilot Study
Alcohol Use Disorder
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.
Sarah Johnson, PhD contact
Joshua Vande Hey, PhD study chair
University of Leicester
Antonella Ghezzi principal investigator
University Hospitals, Leicester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Environment and Sleep, run by University of Leicester at 1 site in United Kingdom.
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 4 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 8 Jun 2026. 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 United Kingdom. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rikesh Panchal, PhD (+44(0)116 229 7659, rp173@leicester.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 21 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06802367, which also lists 16 linked publications.
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 8 Jun 2026.