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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03774212
Recruitment Status : Completed
First Posted : December 12, 2018
Last Update Posted : August 12, 2019
Sponsor:
Collaborator:
NHS Lothian
Information provided by (Responsible Party):
University of Edinburgh

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.


Condition or disease Intervention/treatment Phase
Sleep Deprivation Sleep Device: Active noise cancelling headphones Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Do Active Noise Cancelling Headphones With White Noise Masking Improve Sleep in Non-ventilated, Non-delirious Critical Care Patients?
Actual Study Start Date : February 5, 2019
Actual Primary Completion Date : March 18, 2019
Actual Study Completion Date : April 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Critical Care Noise

Arm Intervention/treatment
Experimental: Group A
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
The white noise will play from an 'iPod touch' (Apple), through the active noise cancelling headphones.
Other Name: White noise masking

Experimental: Group B
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
The white noise will play from an 'iPod touch' (Apple), through the active noise cancelling headphones.
Other Name: White noise masking




Primary Outcome Measures :
  1. Change in score on the Richards-Campbell sleep questionnaire. [ Time Frame: Day 1 and day 2 after participant's enrolment. Completed throughout the 6 month study duration. ]
    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 :
  1. Patient experience [ Time Frame: Day 2 after participant's enrolment. Completed throughout the 6 month study duration. ]
    Patients will fill out a questionnaire about their experience. Participants will be required to circle an appropriate descriptive word to answer each question.

  2. Actigraphy data [ Time Frame: Night 1 and 2 of participant's enrolment. Completed throughout the 6 month study duration. ]

    The wrist band provides:

    • Total sleep time
    • Deep sleep time
    • Light sleep Time



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03774212


Locations
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United Kingdom
The Royal Infirmary of Edinburgh
Edinburgh, United Kingdom, EH16 4SA
Sponsors and Collaborators
University of Edinburgh
NHS Lothian
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Responsible Party: University of Edinburgh
ClinicalTrials.gov Identifier: NCT03774212    
Other Study ID Numbers: AC18134
First Posted: December 12, 2018    Key Record Dates
Last Update Posted: August 12, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We will not be sharing individual participant data with other researchers

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Edinburgh:
Critical care patients
High dependency unit
Intensive care unit
Additional relevant MeSH terms:
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Sleep Deprivation
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Neurologic Manifestations
Mental Disorders