White Noise for Sleep
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Scripps Health
No Placebo Group
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.
12345Is 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.
12367How 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.
128910Eligibility 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.
Trial 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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Night A active white noiseExperimental Treatment1 Intervention
Patients receiving active level of white noise on night A
Group II: Night B inactive white noisePlacebo Group1 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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Scripps HealthLa Jolla, CA
Loading ...
Who Is Running the Clinical Trial?
Scripps HealthLead Sponsor
References
Broadband Sound Administration Improves Sleep Onset Latency in Healthy Subjects in a Model of Transient Insomnia. [2022]Insomnia is a major public health problem in western countries. Previous small pilot studies showed that the administration of constant white noise can improve sleep quality, increase acoustic arousal threshold, and reduce sleep onset latency. In this randomized controlled trial, we tested the effect of surrounding broadband sound administration on sleep onset latency, sleep architecture, and subjective sleep quality in healthy subjects.
Noise as a sleep aid: A systematic review. [2021]White noise is purported to mask disruptive noises in the bedroom environment and be a non-pharmacological approach for promoting sleep and improving sleep quality. We conducted a systematic review of all studies examining the relationships between continuous white noise or similar broadband noise and sleep (PROSPERO 2020: CRD42020148736). Animal studies and studies using intermittent white noise to disrupt sleep or enhance slow wave activity were excluded. Two reviewers independently screened titles and abstracts of articles from three databases and assessed risk of bias for the 38 included articles. The primary outcomes described sleep onset latency, sleep fragmentation, sleep quality, and sleep and wake duration. There was heterogeneity in noise characteristics, sleep measurement methodology, adherence to the intervention, control group conditions or interventions, and presence of simultaneous experimental interventions. There was perhaps resultantly variability in research findings, with the extremes being that continuous noise improves or disrupts sleep. Following the GRADE criteria, the quality of evidence for continuous noise improving sleep was very low, which contradicts its widespread use. Additional research with objective sleep measures and detailed descriptions of noise exposure is needed before promoting continuous noise as a sleep aid, especially since it may also negatively affect sleep and hearing.
Systematic review: auditory stimulation and sleep. [2023]Auditory stimulation devices (white and pink noise) are used to mask sounds and facilitate relaxation and sleep; however, the effectiveness of this intervention is not well established. This systematic review examined the scientific literature for the effect of specific types of auditory stimulation on sleep outcomes in adults.
Effect of White Noise on Sleep in Patients Admitted to a Coronary Care. [2022]Sleep disorders are a common problem in patients in the critical care unit. The objective of the present study was to determine the effect of white noise on the quality of sleep in patients admitted to the CCU.
Effects of two types of ambient sound during sleep. [2009]This field study investigated whether either of two ambient sounds would improve objective sleep (via actigraphy), subjective sleep report, or morning psychomotor performance among 28 adults with self-described disturbed sleep. Nights 1 and 4 were soundless baseline and washout, respectively. On Nights 2 and 3 and 5 and 6, participants listened to double-blind counterbalanced paired nights of novel Sound A and a commercially available Sound B. Compared to baseline and washout, participants reported fewer awakenings during both Sound A and Sound B; actigraphically measured sleep was affected by Sound B but not Sound A. "Improvements" in sleep during the second exposure night probably reflect an increase in homeostatic sleep drive from sleep disturbance on the first exposure night. Differences between sounds were accounted for by user volume settings. Neither sound led to differences in psychomotor performance.
Evidence based complementary intervention for insomnia. [2006]Increasing scientific evidence point to a non-pharmacological complementary treatment for insomnia: white noise. Its presentation has been shown to induce sleep in human neonates and adults, probably by reducing the signal-to-noise ratio of ambient sound. White noise may be a simple, safe, cost-effective alternative to hypnotic medication in many psychiatric disorders, especially acute stress disorder and PTSD.
The effects of white noise on sleep and duration in individuals living in a high noise environment in New York City. [2021]Undisturbed sleep has been shown to be important for both health and quality of life (Medic et al. [7]). The World Health Organization estimates that nearly 25% of the population suffers from disturbed sleep due to environmental noise (Health TWECfEa, [2]). Sleep disturbance associated with elevated noise levels is particularly prevalent in metropolitan areas. Our study tested the hypothesis that white noise would improve sleep in New Yorkers complaining of sleep difficulty due to elevated sound levels.
Tinnitus treatment with sound stimulation during sleep. [2011]A new strategy for idiopathic subjective tinnitus treatment - sound stimulation during sleep - has been applied. It was based on the acknowledgement that the auditory system also works during sleep, processing the incoming information. Eleven patients were stimulated every night during 6 months. The stimulus was a sound that mimetized the tinnitus and was fixed at the same tinnitus intensity, applied through an iPod. All patients decreased their tinnitus intensity in the first month of treatment (statistically significant), most of them in the first week. Tinnitus intensity continued decreasing in the following weeks; three patients presented periods of total silence.
Validation of a Mobile Device for Acoustic Coordinated Reset Neuromodulation Tinnitus Therapy. [2020]Sound-based tinnitus intervention stimuli include broad-band noise signals with subjectively adjusted bandwidths used as maskers delivered by commercial devices or hearing aids, environmental sounds broadly described and delivered by both consumer devices and hearing aids, music recordings specifically modified and delivered in a variety of different ways, and other stimuli. Acoustic coordinated reset neuromodulation therapy for tinnitus reduction has unique and more stringent requirements compared to all other sound-based tinnitus interventions. These include precise characterization of tinnitus pitch and loudness, and effective provision of patient-controlled daily therapy signals at defined frequencies, levels, and durations outside of the clinic.
Using therapeutic sound with progressive audiologic tinnitus management. [2022]Management of tinnitus generally involves educational counseling, stress reduction, and/or the use of therapeutic sound. This article focuses on therapeutic sound, which can involve three objectives: (a) producing a sense of relief from tinnitus-associated stress (using soothing sound); (b) passively diverting attention away from tinnitus by reducing contrast between tinnitus and the acoustic environment (using background sound); and (c) actively diverting attention away from tinnitus (using interesting sound). Each of these goals can be accomplished using three different types of sound-broadly categorized as environmental sound, music, and speech-resulting in nine combinations of uses of sound and types of sound to manage tinnitus. The authors explain the uses and types of sound, how they can be combined, and how the different combinations are used with Progressive Audiologic Tinnitus Management. They also describe how sound is used with other sound-based methods of tinnitus management (Tinnitus Masking, Tinnitus Retraining Therapy, and Neuromonics).