Sleep Headphones and HDU: a Novel Intervention and Sound Evaluation

Study Overview
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Brief Summary
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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.

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

Conditions
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Sleep Deprivation, Sleep

Intervention / Treatment
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* Device: Active noise cancelling headphones


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Critical care patient in Royal Infirmary of Edinburgh Exclusion Criteria: < 18 years of age If the patient is delirious. This will be clarified by asking the nurses, who use the Confusion Assessment method for the ICU (CAM-ICU) Score. If the patient is receiving any form of ventilation (invasive or non-invasive ventilation, continuous positive airway pressure (CPAP), High flow nasal oxygen (HFNO) or respiratory support at night) Physical reasons why they can't wear over-ear headphones Pre-existing severe hearing impairment Previous participation in the study. If the patient is likely to receive medical interventions during the night that would disturb their sleep. Patients expected to leave the critical care wards within the following 48hours. Refusing consent or inability to give consent.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>On study night 1, participants will receive standard care (no headphones provided). On study night 2, these patients will wear Active Noise Cancelling headphones playing white noise. | Device: Active noise cancelling headphones<br>* The white noise will play from an 'iPod touch' (Apple), through the active noise cancelling headphones.<br>* Other names: White noise masking;|
| Experimental: Group B<br>Patients will spend night 1 wearing Active Noise Cancelling headphones playing white noise. On Study night 2, these patients will receive standard care (no headphones provided). | Device: Active noise cancelling headphones<br>* The white noise will play from an 'iPod touch' (Apple), through the active noise cancelling headphones.<br>* Other names: White noise masking;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in score on the Richards-Campbell sleep questionnaire. | Richards-Campbell sleep questionnaire is a series of 5 Visual analog scales that are 100mm long, and range from best possible to worst possible. The final result is calculated by taking a mean of the distances along each line (from left to right). | Day 1 and day 2 after participant's enrolment. Completed throughout the 6 month study duration. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient experience | Patients will fill out a questionnaire about their experience. Participants will be required to circle an appropriate descriptive word to answer each question. | Day 2 after participant's enrolment. Completed throughout the 6 month study duration. | 
| Actigraphy data | The wrist band provides: Total sleep time Deep sleep time Light sleep Time | Night 1 and 2 of participant's enrolment. Completed throughout the 6 month study duration. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Critical care patients, High dependency unit, Intensive care unit