Sleep Headphones and HDU: a Novel Intervention and Sound Evaluation (SHH: Noise!)
Primary Purpose
Sleep Deprivation, Sleep
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Active noise cancelling headphones
Sponsored by
About this trial
This is an interventional treatment trial for Sleep Deprivation focused on measuring Critical care patients, High dependency unit, Intensive care unit
Eligibility Criteria
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.
Sites / Locations
- The Royal Infirmary of Edinburgh
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Group A
Group B
Arm Description
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.
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).
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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.
Actigraphy data
The wrist band provides:
Total sleep time
Deep sleep time
Light sleep Time
Full Information
NCT ID
NCT03774212
First Posted
December 7, 2018
Last Updated
August 9, 2019
Sponsor
University of Edinburgh
Collaborators
NHS Lothian
1. Study Identification
Unique Protocol Identification Number
NCT03774212
Brief Title
Sleep Headphones and HDU: a Novel Intervention and Sound Evaluation
Acronym
SHH: Noise!
Official Title
Do Active Noise Cancelling Headphones With White Noise Masking Improve Sleep in Non-ventilated, Non-delirious Critical Care Patients?
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
February 5, 2019 (Actual)
Primary Completion Date
March 18, 2019 (Actual)
Study Completion Date
April 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Edinburgh
Collaborators
NHS Lothian
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Deprivation, Sleep
Keywords
Critical care patients, High dependency unit, Intensive care unit
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Experimental
Arm Description
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.
Arm Title
Group B
Arm Type
Experimental
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
Active noise cancelling headphones
Other Intervention Name(s)
White noise masking
Intervention Description
The white noise will play from an 'iPod touch' (Apple), through the active noise cancelling headphones.
Primary Outcome Measure Information:
Title
Change in score on the Richards-Campbell sleep questionnaire.
Description
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).
Time Frame
Day 1 and day 2 after participant's enrolment. Completed throughout the 6 month study duration.
Secondary Outcome Measure Information:
Title
Patient experience
Description
Patients will fill out a questionnaire about their experience. Participants will be required to circle an appropriate descriptive word to answer each question.
Time Frame
Day 2 after participant's enrolment. Completed throughout the 6 month study duration.
Title
Actigraphy data
Description
The wrist band provides:
Total sleep time
Deep sleep time
Light sleep Time
Time Frame
Night 1 and 2 of participant's enrolment. Completed throughout the 6 month study duration.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
The Royal Infirmary of Edinburgh
City
Edinburgh
ZIP/Postal Code
EH16 4SA
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
We will not be sharing individual participant data with other researchers
Learn more about this trial
Sleep Headphones and HDU: a Novel Intervention and Sound Evaluation
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