← Back to Search

Night A active white noise for Sleep Fragmentation

N/A

Recruiting

Research Sponsored by Scripps Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Admitted to inpatient internal medicine service for at least 3 nights

Over 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 72 hours

Awards & highlights

Study Summary

This trial aims to improve sleep quality for patients in the hospital by using white noise. Many patients have trouble falling asleep and staying asleep due to noise in the hospital. The researchers will enroll 45 adults

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

There may not be significant side effects from this intervention as it involves only exposure to different levels of white noise during sleep. However, some individuals might find certain sound levels uncomfortable or disruptive to their rest.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

Select...

I am over 18 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 72 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~72 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and 72 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Sleep duration

Sleep fragmentation

Sound level changes ≥ 17.5 dB

+1 more

Secondary outcome measures

Delirium Incidence

Delirium

Morning blood glucose

+4 more

Trial Design

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.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Scripps HealthLead Sponsor

55 Previous Clinical Trials

43,411 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current number of participants being enrolled in this research project?

"Indeed, the information on clinicaltrials.gov confirms that this trial is presently seeking individuals to participate. The study was initially published on July 28th, 2022 and most recently updated on January 22nd, 2024. It aims to recruit a total of 50 participants from a single location."

Answered by AI

Are participants currently being recruited for this study?

"Indeed, the data available on clinicaltrials.gov confirms that this trial is currently seeking participants. The initial posting of the trial occurred on July 28th, 2022 and was most recently updated on January 22nd, 2024. This particular study aims to recruit a total of 50 patients from one designated site."

Answered by AI

What is the primary objective of this clinical trial?

"The main objective of this clinical trial is to evaluate sleep duration within a 72-hour time period. Secondary outcomes include morning blood glucose levels, measured using either morning metabolic panels or point-of-care glucose testing; morning blood pressure readings, measured using standard vital signs equipment and including both systolic and diastolic measurements; and the incidence of delirium based on sleep fragmentation, quantified using bCAM assessments. Additionally, in a secondary analysis, researchers will investigate whether individuals with higher levels of sleep fragmentation (measured by actigraphy) exhibit a greater likelihood of developing delirium compared to those with lower levels of sleep disruption."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Sleepless at Scripps: An Inpatient White Noise Study

Stuti Jaiswal 2022. "Sleepless at Scripps: An Inpatient White Noise Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05475262.

All > Sleep Deprivation