White Noise to Improve Sleep in the Medical Intensive Care Unit (MICU): a Pilot and Feasibility Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-27

Study Completion Date

2019-03-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

A feasibility study to evaluate the use of white noise to improve sleeping conditions in an ICU setting.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Anaerobic Antibiotic Usage for Pneumonia in the Medical Intensive Care Unit

NCT03046082

Pneumonia

COMPLETED

Reduction of Bacterial Resistance With Inhaled Antibiotics in the Intensive Care Unit

NCT01878643

Respiratory Infection Bacterial Resistance Respiratory Failure

COMPLETED EARLY_PHASE1

Analysis of Factors Related to Occurrence of Serious Adverse Events During Nursing in Intensive Care Units

NCT03475238

Nursing Caries Critical Care

COMPLETED

Prevention of Ventilator Associated Pneumonia With Toothbrushing in Oral Care of Critically Ill Mechanically Ventilated Patients

NCT02400294

Critical Care Mechanical Ventilation Ventilator Associated Pneumonia Prevention +2 more

COMPLETED

Airway Microbiome Changes After Artificial Airway Exchange in Critically-ill Pediatric Patients.

NCT06201130

Tracheostomy Endotracheal Tube Ventilator Associated Pneumonia +4 more

RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The ICU is full of alarms and critically ill patients, so it is no surprise that sleep is very much fragmented and poor in this setting, as documented in numerous studies. White noise is a simple intervention that has been shown to improve sleep, including in the ICU setting. The aim is to conduct a pilot trial evaluating the feasibility of providing white noise to patients in the ICU at night to help improve sleep. The plan to measure feasibility metrics including patient acceptance, patient tolerance, and intervention fidelity; also to seek feedback from patients, nurses, and providers. Secondly is to evaluate the benefits of providing white noise at night in the ICU on sleep as measured by actigraphy and Richards-Campbell Sleep Questionnaires and total room sound.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Sleep Deprivation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

patients exposed to white noise

Six patients in the interventional arm will have white noise (through in-room workstations- on-wheels and publicly-available white noise websites) playing overnight at a standardized volume to be determined; pausing will be at nurse, provider, and patient discretion during routine care and conversations with the patients.

Group Type EXPERIMENTAL

white noise

Intervention Type DEVICE

Patients in the interventional arm will have white noise (through in-room workstations- on-wheels and publicly-available white noise websites) playing overnight at a standardized volume to be determined.

usual care

Six patients exposed to normal ICU activity noise.

Group Type PLACEBO_COMPARATOR

usual care

Intervention Type BEHAVIORAL

normal ICU activity noise

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

white noise

Patients in the interventional arm will have white noise (through in-room workstations- on-wheels and publicly-available white noise websites) playing overnight at a standardized volume to be determined.

Intervention Type DEVICE

usual care

normal ICU activity noise

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Adults \>18yo admitted to MICU with expected stay of at least two nights after enrollment

Exclusion Criteria

* Excluding intubated patients (so communication can be better) and patients on high-flow nasal cannula (which is already high background noise).
* Patients who are on therapeutic hypothermia or are on comfort measures only will also be excluded

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes