Sleep Headphones and HDU: a Novel Intervention and Sound Evaluation — SHH: Noise!  

Sleep Clinical Trial

Official title: Do Active Noise Cancelling Headphones With White Noise Masking Improve Sleep in Non-ventilated, Non-delirious Critical Care Patients?

Status Completed

Clinical Trial Summary

It is well established that patients sleep poorly in the Intensive Care Unit (ICU), and excessive noise is considered to be a modifiable cause of this. Previous studies have tried to reduce ambient noise by educating staff and fixing noisy equipment. Other studies have tried to reduce the noise experienced by patients by supplying them with active noise cancelling headphones and earplugs. In this study we are combining Active Noise Cancelling headphones with white noise to try and reduce noise experienced by patients, with the aim of improving their sleep. Sleep deprivation is known to negatively impact health, and so improving sleep may improve patient outcomes as well as improve the patient's experience in critical care.

The Investigators will screen all patients in the critical care wards in the Royal Infirmary of Edinburgh. Patients that are receiving ventilation, are delirious or have already been enrolled in the study will be excluded. After allowing patients to give informed consent, we will randomise them into one of two study groups:

Study group A will receive standard care on the 1st night (no headphones), and will receive the intervention (active noise cancelling headphones with white noise) on the 2nd night.

Study group B will receive the intervention on the 1st night, and will receive standard care on the 2nd night.

All patients will wear a Xiaomi MiBand 2 wrist band, that tracks movement and sleep.

Patients will fill in the Pittsburgh Sleep Quality Index at the beginning of the study to establish usual sleeping habits.

Our primary outcome measure is the mean score on the Richard Campbell Sleep Questionnaire (RCSQ), which will be filled in by the patient the morning after each night.

Our secondary outcome measure is the data from the wrist band, noise levels measured overnight, and patient experience of the intervention.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Sleep
• Sleep Deprivation

• NCT number: NCT03774212
• Study type: Interventional
• Source: University of Edinburgh
• Status: Completed
• Phase: N/A
• Start date: February 5, 2019
• Completion date: April 1, 2019