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NCT01343095 · ClinicalTrials.gov registry record · NA

Direct Noise Reduction in the Intensive Care Units (ICU) Using Earplugs and Noise Canceling Headphones

A NA study, sponsored by Wake Forest University.

Terminated
Registry status
NA
Development phase
8
Enrollment target

NCT01343095: Clinical Trial NA study, sponsored by Wake Forest University.

NCT01343095 is a NA study that was terminated before completion, run by Wake Forest University. The registered enrollment target is 8 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01343095, a NA study, was terminated before completion, sponsored by Wake Forest University.

TERMINATED
Registry status
NA
Development phase
8 participants
Enrollment target

Study Summary

This study seeks to examine the effects of overnight noise reduction in critically ill patients who are receiving mechanical ventilation. The investigators will randomly place subjects into one of three groups: 1) usual care 2) overnight earplugs 3) overnight earplugs and noise-canceling headphones. The investigators will monitor for safety, and will measure the amount of delirium experienced by subjects, record the amount of sedating and painkilling medicines required, and measure sleep quality during the study, among other information. The investigators will also measure noise levels experienced by patients in each group. The investigators predict that the use of overnight noise reduction will be safe and will reduce the amount of delirium by improving the quality of sleep in critically ill patients.

Interventions

  • DEVICE Foam Earplugs
  • DEVICE Noise Canceling Headphones

Trial Details

FieldValue
Enrollment Target 8 participants
Start Date 2011-05
Est. Completion 2015-06
Phase NA
Wake Forest University

100 total trials

Why NCT01343095 stopped before completion

NCT01343095 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).

The record links to 0 conditions, and to 2 interventions - of which Foam Earplugs is the first listed.

NCT01343095 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01343095 about?

NCT01343095 is a clinical study titled "Direct Noise Reduction in the Intensive Care Units (ICU) Using Earplugs and Noise Canceling Headphones". This study seeks to examine the effects of overnight noise reduction in critically ill patients who are receiving mechanical ventilation. The investigators will randomly place subjects into one of three groups: 1) usual care 2) overnight earplugs 3) overnight earplugs and noise-canceling headphones....

What is the current status of trial NCT01343095?

This trial is currently terminated. It is a NA study. The enrollment target is 8 participants. The study started on 2011-05. Estimated completion is 2015-06.

What interventions are being tested in trial NCT01343095?

The interventions under investigation include: Foam Earplugs (DEVICE), Noise Canceling Headphones (DEVICE).

Who is sponsoring clinical trial NCT01343095?

This trial is sponsored by Wake Forest University, which has 100 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01343095's enrollment target sits among peer trials

8 1976th of 2000 higher than 19 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01343095, the US trial registry maintained by the National Library of Medicine. NCT01343095 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.