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. 2018 Nov 23;2018(11):CD009783. doi: 10.1002/14651858.CD009783.pub2

Miles 2012.

Trial name or title A randomised controlled trial of direct noise reduction in the ICU
Country: USA
Methods A 3‐arm randomized controlled trial to establish the feasibility of the interventions and their ability to impact noise, sleep, and delirium.
Participants Mechanically ventilated ICU patients. Expected n = 45
Interventions Intervention
  1. Earplugs

  2. Earplugs plus noise‐cancelling headphones overnight during 7 days of the ICU stay


Control
  1. Usual care

Outcomes
  1. Delirium measured by CAM‐ICU

  2. Measurement of sound levels both in the patient's room as well as within the ear canal, and a limited sleep EEG

  3. Additional measurements include amount of sedative, analgesic, and antipsychotic medications

  4. Hospital and ICU length of stay.

Starting date Unknown
Contact information Dr. Hite. Clevaland Clinic Main Campus, Cleveland, Ohio, USA
Notes Study number: unknown
Status: in 2012 was n = 8 were enrolled
Contact with authors: Dr Hite was contacted by post 14 September 2016 for further information and status on the study — we are awaiting response.