White Noise for Sleep

Overseen By Stuti Jaiswal, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Scripps Health

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 3 nights

50 Participants Needed

Trial Summary

What is the purpose of this trial?

Sleep is an important part of the healing process, and patients admitted to the hospital often report poor sleep. Patients have difficulty not only falling sleep, but also staying asleep. Prior studies show that hospital noise may be a contributing factor, and in particular, sound level changes (which refers to an increase in sound above the background/baseline noise level) may cause arousals from sleep. Based on preliminary data, this study aims to use white noise to reduce the number of relevant sound level changes that occur during a night of sleep in the hospital. Using a randomized, cross-over design, the investigators aim to enroll 45 inpatient adults (age ≥ 65 years) to receive "active," white noise (white noised played at 57-60 decibels) on one night of their stay, and "inactive," white noise (white noise played at 45-50 decibels) on an alternate night. Three major primary outcomes will be investigated - 1) objective sleep duration as measured using actigraphy, 2)objectively measured sleep fragmentation using actigraphy, and 3) subjective sleep quality using the Richards Campbell Sleep Questionnaire. Secondary outcomes will include sound level changes in the room (measured using sound meters), as well as morning blood glucose (for diabetic/prediabetic patients) and blood pressure measurements. Delirium will be measured twice daily through the inpatient stay in a secondary analysis to compare levels of sleep fragmentation to delirium incidence.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment White Noise for Sleep?

Research suggests that constant white noise can improve sleep quality and reduce the time it takes to fall asleep, as seen in studies with healthy subjects and patients in critical care. However, the overall quality of evidence is low, and more research is needed to confirm these findings. ^{1 2 3 4 5}

Is white noise safe for use in humans?

White noise is generally considered safe for humans and is often used as a non-drug method to help with sleep. However, some studies suggest it might negatively affect sleep and hearing, so more research is needed to fully understand its safety. ^{1 2 3 6 7}

How does white noise treatment for sleep differ from other treatments?

White noise treatment is unique because it uses continuous sound to mask disruptive noises, potentially improving sleep quality and reducing the time it takes to fall asleep without the use of medication. Unlike other treatments, it is a non-pharmacological approach that can be easily administered in a home setting. ^{1 2 8 9 10}

Eligibility Criteria

This trial is for adults over 18 who are admitted to the inpatient internal medicine service for at least three nights. It's designed to help those experiencing poor sleep in the hospital by testing if white noise can improve their sleep quality and duration.

Inclusion Criteria

I have been hospitalized in the internal medicine department for at least 3 nights.

I am over 18 years old.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive white noise intervention during their hospital stay, with active and inactive white noise on different nights

3 nights

Inpatient stay

Follow-up

Participants are monitored for sleep quality, delirium incidence, and other health metrics

72 hours

Treatment Details

Interventions

• Active white noise
• Inactive white noise

Trial Overview The study compares two levels of white noise: 'active' (57-60 decibels) and 'inactive' (45-50 decibels). Each participant will experience both on different nights. The effects on sleep duration, fragmentation, and subjective quality will be measured, along with room noise levels, blood glucose, blood pressure, and delirium incidence.

Participant Groups

Group I: Night A active white noise Experimental Treatment 1 Intervention

Patients receiving active level of white noise on night A

Group II: Night B inactive white noise Placebo Group 1 Intervention

Patients will receive a lower Level of white noise on night B. Termed "inactive," because do not expect the level to have a noticeable change in sound level changes, and thus sleep.

Who Is Running the Clinical Trial?

Scripps Health

Lead Sponsor

Trials

59

Recruited

43,400+

Findings from Research

In a study involving 18 healthy subjects, the use of broadband sound significantly reduced the time it took to fall asleep by 38% compared to normal environmental noise, indicating its potential effectiveness in improving sleep onset latency.

For individuals who typically have trouble falling asleep, broadband sound administration also enhanced subjective sleep quality and reduced the frequency of sleep arousals, suggesting it could be a beneficial intervention for managing insomnia symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Broadband Sound Administration Improves Sleep Onset Latency in Healthy Subjects in a Model of Transient Insomnia. Messineo, L., Taranto-Montemurro, L., Sands, SA., et al.[2022]

A systematic review of 38 studies found that the evidence supporting continuous white noise as a sleep aid is very low quality, suggesting it may not reliably improve sleep outcomes.

The review highlighted significant variability in research findings, with some studies indicating that white noise could disrupt sleep, raising concerns about its safety and effectiveness as a sleep intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Noise as a sleep aid: A systematic review. Riedy, SM., Smith, MG., Rocha, S., et al.[2021]

A systematic review of 34 studies involving 1,103 participants found that pink noise was particularly effective in improving sleep outcomes, with 81.9% of studies reporting positive results, compared to 33% for white noise.

No adverse effects were reported from the short-term use of auditory stimulation during sleep, suggesting that these interventions are safe, although the overall evidence for their effectiveness remains weak.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic review: auditory stimulation and sleep. Capezuti, E., Pain, K., Alamag, E., et al.[2023]

In a study of 60 patients in a critical care unit, the use of white noise did not significantly change the average sleep duration or quality compared to a control group, suggesting that it may not be effective for improving sleep in this setting.

Despite the lack of significant changes in sleep metrics, the study recommends white noise as a method to mask environmental sounds, which could help maintain sleep quality in the coronary care unit.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of White Noise on Sleep in Patients Admitted to a Coronary Care. Farokhnezhad Afshar, P., Bahramnezhad, F., Asgari, P., et al.[2022]

In a study involving 28 adults with disturbed sleep, both Sound A and Sound B were found to reduce the number of awakenings compared to baseline, indicating potential benefits for subjective sleep quality.

While Sound B showed some effects on objectively measured sleep, neither sound improved morning psychomotor performance, suggesting that while ambient sounds may help with sleep disturbances, they do not necessarily enhance daytime functioning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of two types of ambient sound during sleep. Montgomery-Downs, HE., Insana, SP., Miller, EA.[2009]

White noise has been identified as a non-pharmacological treatment for insomnia, showing effectiveness in promoting sleep in both neonates and adults by reducing ambient sound disturbances.

This method is considered a safe, simple, and cost-effective alternative to traditional sleep medications, particularly beneficial for individuals with psychiatric conditions like acute stress disorder and PTSD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evidence based complementary intervention for insomnia. López, HH., Bracha, AS., Bracha, HS.[2006]

In a study involving 10 adults from a New York City sleep clinic, the use of white noise significantly improved sleep quality, as evidenced by reduced wake after sleep onset (WASO) and shorter sleep latency.

The findings suggest that white noise can be an effective intervention for individuals experiencing sleep disturbances due to high environmental noise, highlighting its potential as a practical tool for improving sleep in noisy urban settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of white noise on sleep and duration in individuals living in a high noise environment in New York City. Ebben, MR., Yan, P., Krieger, AC.[2021]

In a study involving 11 patients with idiopathic subjective tinnitus, sound stimulation during sleep significantly reduced tinnitus intensity, with most patients experiencing improvement within the first week of treatment.

Over a 6-month period, the treatment led to continued decreases in tinnitus intensity, and three patients even reported periods of total silence, suggesting a promising new approach for managing this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tinnitus treatment with sound stimulation during sleep. M, P., D, D., S, R., et al.[2011]

Mobile devices can reliably deliver acoustic therapy signals for tinnitus, demonstrating their potential for effective sound-based interventions.

An automated pitch-matching algorithm for tinnitus was found to be as accurate as traditional methods but with significantly less variability, making it easier for patients to use and control their therapy without professional help.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validation of a Mobile Device for Acoustic Coordinated Reset Neuromodulation Tinnitus Therapy. Hauptmann, C., Wegener, A., Poppe, H., et al.[2020]

Therapeutic sound is an effective management strategy for tinnitus, focusing on three main objectives: relieving stress associated with tinnitus, diverting attention from the tinnitus sound, and providing engaging auditory experiences.

The article outlines nine combinations of sound types (environmental sound, music, and speech) that can be used in conjunction with Progressive Audiologic Tinnitus Management and other sound-based therapies, highlighting the versatility of sound in tinnitus treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using therapeutic sound with progressive audiologic tinnitus management. Henry, JA., Zaugg, TL., Myers, PJ., et al.[2022]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Broadband Sound Administration Improves Sleep Onset Latency in Healthy Subjects in a Model of Transient Insomnia. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Noise as a sleep aid: A systematic review. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Systematic review: auditory stimulation and sleep. [2023]

4. Iran pubmed.ncbi.nlm.nih.gov

Effect of White Noise on Sleep in Patients Admitted to a Coronary Care. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Effects of two types of ambient sound during sleep. [2009]

6. United States pubmed.ncbi.nlm.nih.gov

Evidence based complementary intervention for insomnia. [2006]

7. Netherlands pubmed.ncbi.nlm.nih.gov

The effects of white noise on sleep and duration in individuals living in a high noise environment in New York City. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Tinnitus treatment with sound stimulation during sleep. [2011]

9. United States pubmed.ncbi.nlm.nih.gov

Validation of a Mobile Device for Acoustic Coordinated Reset Neuromodulation Tinnitus Therapy. [2020]

10. United States pubmed.ncbi.nlm.nih.gov

Using therapeutic sound with progressive audiologic tinnitus management. [2022]