Sleep DeprivationSHH: Noise!NCT03774212
Sleep Headphones and HDU: a Novel Intervention and Sound Evaluation
A study testing Active noise cancelling headphones in people with Sleep Deprivation and Sleep, run by University of Edinburgh at 1 site in United Kingdom.
Trial summary
It is well established that patients sleep poorly in the Intensive Care Unit (ICU), and excessive noise is considered to be a modifiable cause of this. Previous studies have tried to reduce ambient noise by educating staff and fixing noisy equipment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Deprivation, Sleep
- What is being tested?
- Active noise cancelling headphones
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 5 Feb 2019to 1 Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Critical care patient in Royal Infirmary of Edinburgh
Who cannot join
- < 18 years of age
- If the patient is delirious. This will be clarified by asking the nurses, who use the Confusion Assessment method for the ICU (CAM-ICU) Score.
- If the patient is receiving any form of ventilation (invasive or non-invasive ventilation, continuous positive airway pressure (CPAP), High flow nasal oxygen (HFNO) or respiratory support at night)
- Physical reasons why they can't wear over-ear headphones
- Pre-existing severe hearing impairment
- Previous participation in the study.
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- If the patient is likely to receive medical interventions during the night that would disturb their sleep.
- Patients expected to leave the critical care wards within the following 48hours.
- Refusing consent or inability to give consent.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
The Royal Infirmary of Edinburgh
Edinburgh, EH16 4SA
About this study
Official title: Do Active Noise Cancelling Headphones With White Noise Masking Improve Sleep in Non-ventilated, Non-delirious Critical Care Patients?
It is well established that patients sleep poorly in the Intensive Care Unit (ICU), and excessive noise is considered to be a modifiable cause of this. Previous studies have tried to reduce ambient noise by educating staff and fixing noisy equipment. Other studies have tried to reduce the noise experienced by patients by supplying them with active noise cancelling headphones and earplugs. In this study we are combining Active Noise Cancelling headphones with white noise to try and reduce noise experienced by patients, with the aim of improving their sleep. Sleep deprivation is known to negatively impact health, and so improving sleep may improve patient outcomes as well as improve the patient's experience in critical care.
The Investigators will screen all patients in the critical care wards in the Royal Infirmary of Edinburgh. Patients that are receiving ventilation, are delirious or have already been enrolled in the study will be excluded. After allowing patients to give informed consent, we will randomise them into one of two study groups:
Read more
Study group A will receive standard care on the 1st night (no headphones), and will receive the intervention (active noise cancelling headphones with white noise) on the 2nd night.
Study group B will receive the intervention on the 1st night, and will receive standard care on the 2nd night.
All patients will wear a Xiaomi MiBand 2 wrist band, that tracks movement and sleep.
Patients will fill in the Pittsburgh Sleep Quality Index at the beginning of the study to establish usual sleeping habits.
Our primary outcome measure is the mean score on the Richard Campbell Sleep Questionnaire (RCSQ), which will be filled in by the patient the morning after each night.
Our secondary outcome measure is the data from the wrist band, noise levels measured overnight, and patient experience of the intervention.
- Conditions
- Sleep Deprivation, Sleep
- Being tested
- Active noise cancelling headphones
- Keywords
- Critical care patients, High dependency unit, Intensive care unit
- Medical subject headings
- Sleep Deprivation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active noise cancelling headphonesDevice
Also called White noise masking
The white noise will play from an 'iPod touch' (Apple), through the active noise cancelling headphones.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | On study night 1, participants will receive standard care (no headphones provided). On study night 2, these patients will wear Active Noise Cancelling headphones playing white noise. Receives: Device: Active noise cancelling headphones |
| Group B | Experimental | Patients will spend night 1 wearing Active Noise Cancelling headphones playing white noise. On Study night 2, these patients will receive standard care (no headphones provided). Receives: Device: Active noise cancelling headphones |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in score on the Richards-Campbell sleep questionnaire.
Richards-Campbell sleep questionnaire is a series of 5 Visual analog scales that are 100mm long, and range from "best possible" to "worst possible". The final result is calculated by taking a mean of the distances along each line (from left to right).
Measured: Day 1 and day 2 after participant's enrolment. Completed throughout the 6 month study duration.
Secondary outcomes (2)
Patient experience
Patients will fill out a questionnaire about their experience. Participants will be required to circle an appropriate descriptive word to answer each question.
Measured: Day 2 after participant's enrolment. Completed throughout the 6 month study duration.
Actigraphy data
The wrist band provides:
- Total sleep time
- Deep sleep time
- Light sleep Time
Measured: Night 1 and 2 of participant's enrolment. Completed throughout the 6 month study duration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2018
- Study start5 Feb 2019
- Primary completion18 Mar 2019
- Study completion1 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DeprivationStudies of the same condition, open and under way.
- More trials run by University of EdinburghThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Collaborators
- NHS Lothian
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03774212
- Sponsor's protocol ID
- AC18134
- Acronym
- SHH: Noise!
- Status last verified
- Aug 2019
- First submitted
- 7 Dec 2018
- Last updated
- 12 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We will not be sharing individual participant data with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do Active Noise Cancelling Headphones With White Noise Masking Improve Sleep in Non-ventilated, Non-delirious Critical Care Patients?
- ClinicalTrials.gov ID
- NCT03774212
- Acronym / sponsor ID
- SHH: Noise! / AC18134
- Conditions
- Sleep Deprivation, Sleep
- Keywords
- Critical care patients, High dependency unit, Intensive care unit
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Collaborators
- NHS Lothian
- Study start
- 5 Feb 2019 (actual)
- Primary completion
- 18 Mar 2019 (actual)
- Study completion
- 1 Apr 2019 (actual)
- First posted
- 12 Dec 2018 (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.
It is well established that patients sleep poorly in the Intensive Care Unit (ICU), and excessive noise is considered to be a modifiable cause of this. Previous studies have tried to reduce ambient noise by educating staff and fixing noisy equipment. Other studies have tried to reduce the noise experienced by patients by supplying them with active noise cancelling headphones and earplugs. In this study we are combining Active Noise Cancelling headphones with white noise to try and reduce noise experienced by patients, with the aim of improving their sleep. Sleep deprivation is known to negatively impact health, and so improving sleep may improve patient outcomes as well as improve the patient's experience in critical care.
The Investigators will screen all patients in the critical care wards in the Royal Infirmary of Edinburgh. Patients that are receiving ventilation, are delirious or have already been enrolled in the study will be excluded. After allowing patients to give informed consent, we will randomise them into one of two study groups:
Study group A will receive standard care on the 1st night (no headphones), and will receive the intervention (active noise cancelling headphones with white noise) on the 2nd night.
Study group B will receive the intervention on the 1st night, and will receive standard care on the 2nd night.
All patients will wear a Xiaomi MiBand 2 wrist band, that tracks movement and sleep.
Patients will fill in the Pittsburgh Sleep Quality Index at the beginning of the study to establish usual sleeping habits.
Our primary outcome measure is the mean score on the Richard Campbell Sleep Questionnaire (RCSQ), which will be filled in by the patient the morning after each night.
Our secondary outcome measure is the data from the wrist band, noise levels measured overnight, and patient experience of the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Device: Active noise cancelling headphonesOn study night 1, participants will receive standard care (no headphones provided). On study night 2, these patients will wear Active Noise Cancelling headphones playing white noise. |
| Group B | Experimental | Device: Active noise cancelling headphonesPatients will spend night 1 wearing Active Noise Cancelling headphones playing white noise. On Study night 2, these patients will receive standard care (no headphones provided). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Critical care patient in Royal Infirmary of Edinburgh
Key exclusion criteria (9 listed)
- < 18 years of age
- If the patient is delirious. This will be clarified by asking the nurses, who use the Confusion Assessment method for the ICU (CAM-ICU) Score.
- If the patient is receiving any form of ventilation (invasive or non-invasive ventilation, continuous positive airway pressure (CPAP), High flow nasal oxygen (HFNO) or respiratory support at night)
- Physical reasons why they can't wear over-ear headphones
- Pre-existing severe hearing impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active noise cancelling headphonesAlso: White noise maskingThe white noise will play from an 'iPod touch' (Apple), through the active noise cancelling headphones. | Device | Group A, Group B |
Primary outcome
Change in score on the Richards-Campbell sleep questionnaire.
Time frame: Day 1 and day 2 after participant's enrolment. Completed throughout the 6 month study duration.
Richards-Campbell sleep questionnaire is a series of 5 Visual analog scales that are 100mm long, and range from "best possible" to "worst possible". The final result is calculated by taking a mean of the distances along each line (from left to right).
2 secondary outcomes
Patient experience
Time frame: Day 2 after participant's enrolment. Completed throughout the 6 month study duration.
Actigraphy data
Time frame: Night 1 and 2 of participant's enrolment. Completed throughout the 6 month study duration.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2019.
- Individual participant dataSharing planned: No. We will not be sharing individual participant data with other researchers
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active noise cancelling headphones in people with Sleep Deprivation and Sleep, run by University of Edinburgh 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 1 inclusion and 9 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: finished, as of the sponsor's last update on 12 Aug 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in score on the Richards-Campbell sleep questionnaire. (time frame: Day 1 and day 2 after participant's enrolment. Completed throughout the 6 month study duration.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Aug 2019.