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

Yale University

Status: Completed

Conditions: Sleep Deprivation

Treatments: Behavioral: usual care; Device: white noise

Study type: Interventional

Funder types: Other

Identifiers

NCT03755011

2000024300

Details and patient eligibility

About

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

Full description

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.

Enrollment: 7 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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7 participants in 2 patient groups, including a placebo group

patients exposed to white noise

Experimental group

Description:

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.

Treatment:

Device: white noise

usual care

Placebo Comparator group

Description:

Six patients exposed to normal ICU activity noise.

Treatment:

Behavioral: usual care