SleepNCT05785130
The Effects of White Noise for Adult Patients' Sleep Quality in Intensive Care Unit.
A study testing white noise in people with Sleep, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
Poor sleep quality is one of the most common problems among adult patients in the intensive care unit (ICU). The causes of sleep disturbance are complicated. Poor sleep quality can lead to negative consequences for patients' physical and mental health. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Sleep
- What is being tested?
- white noise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 17 Apr 2023to 28 Nov 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age must be greater than or equal to 20 years old.
- Admitted to the ICU and have been intubated for at least 24 hours.
- Aware of people, time, and place, and without hearing impairment.
- Be able to communicate in writing.
- The Glasgow Coma Scale score must be equal to or greater than 11, with a vocal response of 1 in the patient post-endotracheal tube placement.
Who cannot join
- History of insomnia, Alzheimer's disease, or depression.
- Routine use of sedative-hypnotic drugs (opioids, benzodiazepines, non-benzodiazepines, antihistamines, and melatonin) before admission.
- Post-operation in the operating room before ICU admission.
- ICDSC score of at least 4 or CAM-ICU positive.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of White Noise for Adult Patients' Sleep Quality in Intensive Care Unit: a Randomized Controlled Trial
Poor sleep quality is one of the most common problems among adult patients in the intensive care unit (ICU). The causes of sleep disturbance are complicated. Poor sleep quality can lead to negative consequences for patients' physical and mental health. Non-pharmacological interventions, such as white noise, have been recommended to increase the threshold level of sound during nighttime and achieve masking effects to improve subjective sleep quality. This study is a randomized controlled trial that compared two parallel patient groups.The hypothesis of this study is that white noise can improve sleep quality in adult ICU patients compared with conventional treatment group.
Read the detailed description
Poor sleep quality is one of the most common problems among adult patients in the intensive care unit (ICU). Statistics indicate that over 50% of ICU patients report sleep abnormalities, such as sleep fragmentation, arousals, frequent awakenings, and poor sleep quality. The causes of sleep disturbance are complicated, with evidence suggesting that environmental factors such as noise, from alarms and machines that are active around the clock in the ICU, play a significant role. Poor sleep quality can lead to negative consequences for patients' physical and mental health.
Sleep promotion interventions, including both pharmacological and non-pharmacological approaches, have been proposed. However, the side effects of pharmacological intervention may also lead to poor outcomes. Therefore, non-pharmacological interventions, such as background noise, have been recommended to increase the threshold level of sound during nighttime and achieve masking effects to improve subjective sleep quality.
This study was conducted in randomized controlled trial that compared two parallel patient groups. Patients were included by convenience sampling in a medical center in Taiwan. The Verran and Snyder-Halpern Sleep Scale (VSHSS) was used to assess subjective sleep quality. The main purpose of this study was to investigate the effect of white noise intervention in sleep quality in adult intensive care unit patients.
- Conditions
- Sleep
- Being tested
- white noise
- Keywords
- sleep quality, sleep disturbance, intensive care unit, critically ill patient
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
white noiseOther
Using sound machine for 3 days at bedtime for 7 hours(11p.m.- 6a.m.) in a decibel of 40-50.
| Study group | Role | What they receive |
|---|---|---|
| white noise group | Experimental | Background noise at bedtime. Receives: Other: white noise |
| conventional treatment group | No intervention | Treatment as usual. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Verran and Snyder-Halpern Sleep Scale Scores on Baseline, the First Intervention Day(T1), the Third Intervention Day(T2), and Follow up Two Days Later After Intervention (T3) Between Two Groups.
Sleep quality is assessed using the Verran and Snyder-Halpern (VSH) Sleep Scale, a subjective sleep scale that contains three dimensions: sleep disturbance, sleep effectiveness, and sleep supplementation, with a total of 15 items. Scores are measured using a visual analogue scale, which is a 100mm horizontal line. The maximum score is 100, and the minimum score is 0. The total score of the VSH Sleep Scale (VSHSS) ranges from 0 to 1500. The subscales are combined by summing the individual scores for each item, and the total score is obtained by adding the scores from each of the subscales. The lower the score, the poorer the sleep quality. Outcomes were measured at baseline, the first intervention day (T1), the third intervention day (T2), and two days after the intervention (T3) for both groups.
Measured: Baseline, 1st days, 3rd days and 5th days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2023
- Study start17 Apr 2023
- Primary completion4 Aug 2024
- Study completion28 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SleepStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Kaohsiung Medical University
- Responsible party
- Principal investigator, Ya-Ching, Nien, Chang Gung Memorial Hospital
- Investigators
- Ya-Ching Nien, Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05785130
- Sponsor's protocol ID
- 202300153B0
- Status last verified
- Mar 2025
- First submitted
- 14 Mar 2023
- Last updated
- 17 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of White Noise for Adult Patients' Sleep Quality in Intensive Care Unit: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05785130
- Acronym / sponsor ID
- 202300153B0
- Conditions
- Sleep
- Keywords
- sleep quality, sleep disturbance, intensive care unit, critically ill patient
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Collaborators
- Kaohsiung Medical University
- Study start
- 17 Apr 2023 (actual)
- Primary completion
- 4 Aug 2024 (actual)
- Study completion
- 28 Nov 2024 (actual)
- First posted
- 27 Mar 2023 (actual)
- Results
- Posted 17 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Poor sleep quality is one of the most common problems among adult patients in the intensive care unit (ICU). The causes of sleep disturbance are complicated. Poor sleep quality can lead to negative consequences for patients' physical and mental health. Non-pharmacological interventions, such as white noise, have been recommended to increase the threshold level of sound during nighttime and achieve masking effects to improve subjective sleep quality. This study is a randomized controlled trial that compared two parallel patient groups.The hypothesis of this study is that white noise can improve sleep quality in adult ICU patients compared with conventional treatment group.
Detailed description
Poor sleep quality is one of the most common problems among adult patients in the intensive care unit (ICU). Statistics indicate that over 50% of ICU patients report sleep abnormalities, such as sleep fragmentation, arousals, frequent awakenings, and poor sleep quality. The causes of sleep disturbance are complicated, with evidence suggesting that environmental factors such as noise, from alarms and machines that are active around the clock in the ICU, play a significant role. Poor sleep quality can lead to negative consequences for patients' physical and mental health.
Sleep promotion interventions, including both pharmacological and non-pharmacological approaches, have been proposed. However, the side effects of pharmacological intervention may also lead to poor outcomes. Therefore, non-pharmacological interventions, such as background noise, have been recommended to increase the threshold level of sound during nighttime and achieve masking effects to improve subjective sleep quality.
This study was conducted in randomized controlled trial that compared two parallel patient groups. Patients were included by convenience sampling in a medical center in Taiwan. The Verran and Snyder-Halpern Sleep Scale (VSHSS) was used to assess subjective sleep quality. The main purpose of this study was to investigate the effect of white noise intervention in sleep quality in adult intensive care unit patients.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| white noise group | Experimental | Other: white noiseBackground noise at bedtime. |
| conventional treatment group | No intervention | –Treatment as usual. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age must be greater than or equal to 20 years old.
- Admitted to the ICU and have been intubated for at least 24 hours.
- Aware of people, time, and place, and without hearing impairment.
- Be able to communicate in writing.
- The Glasgow Coma Scale score must be equal to or greater than 11, with a vocal response of 1 in the patient post-endotracheal tube placement.
Key exclusion criteria (4 listed)
- History of insomnia, Alzheimer's disease, or depression.
- Routine use of sedative-hypnotic drugs (opioids, benzodiazepines, non-benzodiazepines, antihistamines, and melatonin) before admission.
- Post-operation in the operating room before ICU admission.
- ICDSC score of at least 4 or CAM-ICU positive.
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 |
|---|---|---|
| white noiseUsing sound machine for 3 days at bedtime for 7 hours(11p.m.- 6a.m.) in a decibel of 40-50. | Other | white noise group |
Primary outcome
The Verran and Snyder-Halpern Sleep Scale Scores on Baseline, the First Intervention Day(T1), the Third Intervention Day(T2), and Follow up Two Days Later After Intervention (T3) Between Two Groups.
Time frame: Baseline, 1st days, 3rd days and 5th days.
Sleep quality is assessed using the Verran and Snyder-Halpern (VSH) Sleep Scale, a subjective sleep scale that contains three dimensions: sleep disturbance, sleep effectiveness, and sleep supplementation, with a total of 15 items. Scores are measured using a visual analogue scale, which is a 100mm horizontal line. The maximum score is 100, and the minimum score is 0. The total score of the VSH Sleep Scale (VSHSS) ranges from 0 to 1500. The subscales are combined by summing the individual scores for each item, and the total score is obtained by adding the scores from each of the subscales. The lower the score, the poorer the sleep quality. Outcomes were measured at baseline, the first intervention day (T1), the third intervention day (T2), and two days after the intervention (T3) for both groups.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Ya-Ching Nien principal investigator
Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing white noise in people with Sleep, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 5 inclusion and 4 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 17 Mar 2025. 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 Taiwan. 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?
Yes. Results are posted in the registry (first posted 17 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The Verran and Snyder-Halpern Sleep Scale Scores on Baseline, the First Intervention Day(T1), the Third Intervention Day(T2), and Follow up Two Days Later After Intervention (T3) Between Two Groups. (time frame: Baseline, 1st days, 3rd days and 5th days.). 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 17 Mar 2025.