Delirium in Old AgeNCT03485183
The Effect of White and Pink Noise on Hospitalized Older Adults
A study testing White/Pink Noise in people with Delirium in Old Age, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
The purpose of this study is to determine if using an over-the-counter, commercially available sleep noise machine playing pink or white noise will reduce the incidence of delirium in hospitalized patients over the age of 65. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Delirium in Old Age
- What is being tested?
- White/Pink Noise
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2018to 8 Dec 2018
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- English-speaking
- 65 years of age or older
- have an estimated hospital stay of 3 or more nights
- have no known hearing deficits or wear hearing aids
- be free of delirium on admission
- be legally able to consent
Who cannot join
- non-English-speaking
- less than 65 years of age
- have known hearing deficits or wear hearing aids
- have delirium on admission
- cannot legally consent to participation
- transferred to/from the ICU before/during being enrolled in the study
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine if using an over-the-counter, commercially available sleep noise machine playing pink or white noise will reduce the incidence of delirium in hospitalized patients over the age of 65. Delirium is an acute change in cognition which commonly occurs in hospitalized older adults, and is linked with sleep-wake cycle disturbance. Delirium is associated with increased morbidity and mortality as well as longer hospital stays. This project will record delirium screening scores for those receiving the intervention and comparing them to baseline data. Reducing delirium rates using a noninvasive, inexpensive method in a hospital setting could have a significant impact on patient outcomes and potentially reduce costs associated with longer hospital stays. It is anticipated that white/pink noise played at night will decrease rates of delirium in hospitalized older adults.
Read the detailed description
The purpose of this study is to determine if using an over-the-counter, commercially available sleep noise machine playing pink or white noise will reduce the incidence of delirium in hospitalized patients over the age of 65. Delirium is an acute change in cognition which commonly occurs in hospitalized older adults, and is linked with sleep-wake cycle disturbance. Delirium is associated with increased morbidity and mortality as well as longer hospital stays. This project will record Nursing Delirium Screening (Nu-DESC) scores for those receiving the intervention and comparing them to baseline data. Reducing delirium rates using a noninvasive, inexpensive method in a hospital setting could have a significant impact on patient outcomes and potentially reduce costs associated with longer hospital stays.
This protocol is based on two concepts. The first is that white/pink noise aids in promoting both sleep quality and quantity and the second is that poor sleep is associated with delirium. Therefore, it stands to reason that improving sleep may decrease the rate of delirium. It is well documented that the elderly are affected by delirium more than other demographics, therefore the benefits to this group would be the greatest in terms of decreasing morbidity and mortality.
White/pink noise was first described as a successful sleep intervention more than 30 years ago in a cardiac intensive care unit study. From that time to present there have been many studies that describe positive effects on sleep by noise machines as a single intervention, but typically they are bundled with other interventions such as earplugs and eye masks. Within the last 5 years, there has been a resurgence in the clinical study of white/pink noise on sleep quality and many of these studies use the gold standard of polysomnography, which employs many sensors to continuously monitor brain waves and sleep patterns. These studies also show a positive impact on both duration and quality of sleep.
More than 15 recent studies were identified that found a correlation between the sleep cycle and delirium. In these studies, sleep disturbance is present in the majority of patients with delirium. There is a clear link between sleep-wake cycle disturbance and delirium, but it is unclear whether an interrupted sleep-wake cycle causes delirium or vice versa. Despite the uncertainty, studies do show that sleep-enhancing interventions decrease rates of delirium and the duration of the delirium. The principal investigator would like to determine if white/pink noise can improve sleep quality and/or quantity, thereby decreasing the incidence of delirium.
- Conditions
- Delirium in Old Age
- Being tested
- White/Pink Noise, Control Group
- Keywords
- delirium, white noise, pink noise
- Medical subject headings
- Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
White/Pink NoiseDevice
White and/or pink noise will be played from 2200 to 0700 using the PicTek® white noise machine.
Control GroupOther
Standard of care including lights on during the day and off at night, getting the patient out of bed for meals, presence of a large wall clock in the room, updating the whiteboard with current day, consistent reorientation of patient, geriatrician consults as needed, and pain management.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | The PI will set up the PicTek white/pink noise machine on the bedside table, and it will automatically turn on at 2200 and off at 0700 to the patient's preferred sound. The staff nurses will chart Nu-DESC scores every shift and as needed for change in mental status as is the current policy. The PI will collect Nu-DESC scores for the duration of the participants' hospital stays, age, race, gender, presence of a dementia diagnosis, and use of a pharmacological sleep aid. Receives: Device: White/Pink Noise |
| Control Group | Other | The PI will perform a chart review of patients who were admitted the month prior to the intervention being implemented. The PI will collect Nu-DESC scores for the duration of the participants' hospital stays, age, race, gender, presence of a dementia diagnosis, and use of a pharmacological sleep aid. These patients will receive the standard of care for delirium prevention. Receives: Other: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nursing Delirium Screening Scale (Nu-DESC) Score
Nursing Delirium Screening Scale (Nu-DESC) scores, which are already routinely charted by staff nurses, will be collected after the PI sets up the white/pink noise intervention. A score of >2 is indicative of delirium.
Measured: Collected every 12-hours shift and as needed for acute change in mental status from baseline through discharge for a minimum of 3 nights not to exceed 14 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2018
- Study start1 Oct 2018
- Primary completion8 Dec 2018
- Study completion8 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Delirium in Old AgeStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be recruited for the intervention group and receive the intervention. Their data will be compared to baseline data--data without personal identifiers retrieved from chart review. These data will serve as the control group.
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Callie Rebecca Sullivan, University of Alabama at Birmingham
- Investigators
- Latricia D Weed, PhD, Principal investigator, Troy University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03485183
- Sponsor's protocol ID
- IRB-300001385
- Status last verified
- Jan 2019
- First submitted
- 26 Mar 2018
- Last updated
- 10 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make individual participant data available at this time since this is a small study. The protocol can be made available to other researchers at their request without the inclusion of IPD ensuring participant privacy.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of White and Pink Noise on Hospitalized Older Adults
- ClinicalTrials.gov ID
- NCT03485183
- Acronym / sponsor ID
- IRB-300001385
- Conditions
- Delirium in Old Age
- Keywords
- delirium, white noise, pink noise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 8 Dec 2018 (actual)
- Study completion
- 8 Dec 2018 (actual)
- First posted
- 2 Apr 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.
The purpose of this study is to determine if using an over-the-counter, commercially available sleep noise machine playing pink or white noise will reduce the incidence of delirium in hospitalized patients over the age of 65. Delirium is an acute change in cognition which commonly occurs in hospitalized older adults, and is linked with sleep-wake cycle disturbance. Delirium is associated with increased morbidity and mortality as well as longer hospital stays. This project will record delirium screening scores for those receiving the intervention and comparing them to baseline data. Reducing delirium rates using a noninvasive, inexpensive method in a hospital setting could have a significant impact on patient outcomes and potentially reduce costs associated with longer hospital stays. It is anticipated that white/pink noise played at night will decrease rates of delirium in hospitalized older adults.
Detailed description
The purpose of this study is to determine if using an over-the-counter, commercially available sleep noise machine playing pink or white noise will reduce the incidence of delirium in hospitalized patients over the age of 65. Delirium is an acute change in cognition which commonly occurs in hospitalized older adults, and is linked with sleep-wake cycle disturbance. Delirium is associated with increased morbidity and mortality as well as longer hospital stays. This project will record Nursing Delirium Screening (Nu-DESC) scores for those receiving the intervention and comparing them to baseline data. Reducing delirium rates using a noninvasive, inexpensive method in a hospital setting could have a significant impact on patient outcomes and potentially reduce costs associated with longer hospital stays.
This protocol is based on two concepts. The first is that white/pink noise aids in promoting both sleep quality and quantity and the second is that poor sleep is associated with delirium. Therefore, it stands to reason that improving sleep may decrease the rate of delirium. It is well documented that the elderly are affected by delirium more than other demographics, therefore the benefits to this group would be the greatest in terms of decreasing morbidity and mortality.
White/pink noise was first described as a successful sleep intervention more than 30 years ago in a cardiac intensive care unit study. From that time to present there have been many studies that describe positive effects on sleep by noise machines as a single intervention, but typically they are bundled with other interventions such as earplugs and eye masks. Within the last 5 years, there has been a resurgence in the clinical study of white/pink noise on sleep quality and many of these studies use the gold standard of polysomnography, which employs many sensors to continuously monitor brain waves and sleep patterns. These studies also show a positive impact on both duration and quality of sleep.
More than 15 recent studies were identified that found a correlation between the sleep cycle and delirium. In these studies, sleep disturbance is present in the majority of patients with delirium. There is a clear link between sleep-wake cycle disturbance and delirium, but it is unclear whether an interrupted sleep-wake cycle causes delirium or vice versa. Despite the uncertainty, studies do show that sleep-enhancing interventions decrease rates of delirium and the duration of the delirium. The principal investigator would like to determine if white/pink noise can improve sleep quality and/or quantity, thereby decreasing the incidence of delirium.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients will be recruited for the intervention group and receive the intervention. Their data will be compared to baseline data--data without personal identifiers retrieved from chart review. These data will serve as the control group.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Device: White/Pink NoiseThe PI will set up the PicTek white/pink noise machine on the bedside table, and it will automatically turn on at 2200 and off at 0700 to the patient's preferred sound. The staff nurses will chart Nu-DESC scores every shift and as needed for change in mental status as is the current policy. The PI will collect Nu-DESC scores for the duration of the participants' hospital stays, age, race, gender, presence of a dementia diagnosis, and use of a pharmacological sleep aid. |
| Control Group | Other | Other: Control GroupThe PI will perform a chart review of patients who were admitted the month prior to the intervention being implemented. The PI will collect Nu-DESC scores for the duration of the participants' hospital stays, age, race, gender, presence of a dementia diagnosis, and use of a pharmacological sleep aid. These patients will receive the standard of care for delirium prevention. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- English-speaking
- 65 years of age or older
- have an estimated hospital stay of 3 or more nights
- have no known hearing deficits or wear hearing aids
- be free of delirium on admission
Key exclusion criteria (6 listed)
- non-English-speaking
- less than 65 years of age
- have known hearing deficits or wear hearing aids
- have delirium on admission
- cannot legally consent to participation
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/Pink NoiseWhite and/or pink noise will be played from 2200 to 0700 using the PicTek® white noise machine. | Device | Intervention Group |
| Control GroupStandard of care including lights on during the day and off at night, getting the patient out of bed for meals, presence of a large wall clock in the room, updating the whiteboard with current day, consistent reorientation of patient, geriatrician consults as needed, and pain management. | Other | Control Group |
Primary outcome
Nursing Delirium Screening Scale (Nu-DESC) Score
Time frame: Collected every 12-hours shift and as needed for acute change in mental status from baseline through discharge for a minimum of 3 nights not to exceed 14 days.
Nursing Delirium Screening Scale (Nu-DESC) scores, which are already routinely charted by staff nurses, will be collected after the PI sets up the white/pink noise intervention. A score of >2 is indicative of delirium.
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 10 Jan 2019.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data available at this time since this is a small study. The protocol can be made available to other researchers at their request without the inclusion of IPD ensuring participant privacy.
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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.
Latricia D Weed, PhD principal investigator
Troy University
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/Pink Noise in people with Delirium in Old Age, run by University of Alabama at Birmingham at 1 site in United States.
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 6 inclusion and 6 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 10 Jan 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 States. 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?
Nursing Delirium Screening Scale (Nu-DESC) Score (time frame: Collected every 12-hours shift and as needed for acute change in mental status from baseline through discharge for a minimum of 3 nights not to exceed 14 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 10 Jan 2019.