Trial Outcomes & Findings for Direct Noise Reduction in the Intensive Care Units (ICU) Using Earplugs and Noise Canceling Headphones (NCT NCT01343095)
NCT ID: NCT01343095
Last Updated: 2018-09-12
Results Overview
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
8 participants
Primary outcome timeframe
During the Study Period (Study Days 0-7 while patients were in ICU)
Results posted on
2018-09-12
Participant Flow
Participant milestones
| Measure |
Usual Care
Usual Care between 10pm-6am
|
Earplugs
Application of earplugs from 10pm-6am nightly for seven nights or until ICU discharge.
Foam Earplugs: Standard Foam Earplugs applied from 10pm-6am nightly. (Sperian Technologies, manufacturer)
|
Earplugs and Headphones
Earplugs and Noise-canceling headphones applied from 10pm-6am nightly for 7 nights or until ICU discharge.
Foam Earplugs: Standard Foam Earplugs applied from 10pm-6am nightly. (Sperian Technologies, manufacturer)
Noise Canceling Headphones: Noise Canceling headphones applied over the ears between 10pm-6am nightly. Model is Bose QuietComfort 15, manufactured by Bose Technologies.
|
|---|---|---|---|
|
Overall Study
STARTED
|
2
|
3
|
3
|
|
Overall Study
COMPLETED
|
2
|
3
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Direct Noise Reduction in the Intensive Care Units (ICU) Using Earplugs and Noise Canceling Headphones
Baseline characteristics by cohort
| Measure |
Usual Care
n=2 Participants
Usual Care between 10pm-6am
|
Earplugs
n=3 Participants
Application of earplugs from 10pm-6am nightly for seven nights or until ICU discharge.
Foam Earplugs: Standard Foam Earplugs applied from 10pm-6am nightly. (Sperian Technologies, manufacturer)
|
Earplugs and Headphones
n=3 Participants
Earplugs and Noise-canceling headphones applied from 10pm-6am nightly for 7 nights or until ICU discharge.
Foam Earplugs: Standard Foam Earplugs applied from 10pm-6am nightly. (Sperian Technologies, manufacturer)
Noise Canceling Headphones: Noise Canceling headphones applied over the ears between 10pm-6am nightly. Model is Bose QuietComfort 15, manufactured by Bose Technologies.
|
Total
n=8 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
72 years
n=5 Participants
|
66 years
n=7 Participants
|
56 years
n=5 Participants
|
63 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=5 Participants
|
3 participants
n=7 Participants
|
3 participants
n=5 Participants
|
8 participants
n=4 Participants
|
|
Mean SAPS II
|
57.5 units on a scale
n=5 Participants
|
40 units on a scale
n=7 Participants
|
57.6 units on a scale
n=5 Participants
|
51 units on a scale
n=4 Participants
|
PRIMARY outcome
Timeframe: During the Study Period (Study Days 0-7 while patients were in ICU)Outcome measures
| Measure |
Usual Care
n=2 Participants
Usual Care between 10pm-6am
|
Earplugs
n=3 Participants
Application of earplugs from 10pm-6am nightly for seven nights or until ICU discharge.
Foam Earplugs: Standard Foam Earplugs applied from 10pm-6am nightly. (Sperian Technologies, manufacturer)
|
Earplugs and Headphones
n=3 Participants
Earplugs and Noise-canceling headphones applied from 10pm-6am nightly for 7 nights or until ICU discharge.
Foam Earplugs: Standard Foam Earplugs applied from 10pm-6am nightly. (Sperian Technologies, manufacturer)
Noise Canceling Headphones: Noise Canceling headphones applied over the ears between 10pm-6am nightly. Model is Bose QuietComfort 15, manufactured by Bose Technologies.
|
|---|---|---|---|
|
Days Free of Delirium or Coma
|
0.5 days
Interval 0.0 to 1.0
|
2.3 days
Interval 0.0 to 6.0
|
2 days
Interval 0.0 to 4.0
|
SECONDARY outcome
Timeframe: Overnight (10pm-6am) on study day 2 or 3.Population: Devices were unable to measure noise above 85 dB(A) from the in-ear location; no noise data was collected.
The reduction in noise experienced by the subject when using the study intervention.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Overnight (10pm-6am) on study day 2 or 3Population: Sleep measurement equipment was not available for use during the study period
Staging of sleep with efficiency determined as a ratio of total sleep time/total study time.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: During the Study Period (Study Days 0-7)Outcome measures
| Measure |
Usual Care
n=2 Participants
Usual Care between 10pm-6am
|
Earplugs
n=3 Participants
Application of earplugs from 10pm-6am nightly for seven nights or until ICU discharge.
Foam Earplugs: Standard Foam Earplugs applied from 10pm-6am nightly. (Sperian Technologies, manufacturer)
|
Earplugs and Headphones
n=3 Participants
Earplugs and Noise-canceling headphones applied from 10pm-6am nightly for 7 nights or until ICU discharge.
Foam Earplugs: Standard Foam Earplugs applied from 10pm-6am nightly. (Sperian Technologies, manufacturer)
Noise Canceling Headphones: Noise Canceling headphones applied over the ears between 10pm-6am nightly. Model is Bose QuietComfort 15, manufactured by Bose Technologies.
|
|---|---|---|---|
|
Amount of Sedative Use (Midazolam and Lorazepam)
Midazolam
|
5 mg
Interval 0.0 to 25.0
|
10.65 mg
Interval 0.0 to 79.5
|
9.22 mg
Interval 0.0 to 63.5
|
|
Amount of Sedative Use (Midazolam and Lorazepam)
Lorazepam
|
0.21 mg
Interval 0.0 to 6.0
|
0.40 mg
Interval 0.0 to 6.5
|
0.39 mg
Interval 0.0 to 2.0
|
SECONDARY outcome
Timeframe: During the Study Period (Study Days 0-7)Mean of analgesic daily use
Outcome measures
| Measure |
Usual Care
n=2 Participants
Usual Care between 10pm-6am
|
Earplugs
n=3 Participants
Application of earplugs from 10pm-6am nightly for seven nights or until ICU discharge.
Foam Earplugs: Standard Foam Earplugs applied from 10pm-6am nightly. (Sperian Technologies, manufacturer)
|
Earplugs and Headphones
n=3 Participants
Earplugs and Noise-canceling headphones applied from 10pm-6am nightly for 7 nights or until ICU discharge.
Foam Earplugs: Standard Foam Earplugs applied from 10pm-6am nightly. (Sperian Technologies, manufacturer)
Noise Canceling Headphones: Noise Canceling headphones applied over the ears between 10pm-6am nightly. Model is Bose QuietComfort 15, manufactured by Bose Technologies.
|
|---|---|---|---|
|
Amount of Analgesic Use
Hydrocodone
|
0 mg
Interval 0.0 to 0.0
|
0 mg
Interval 0.0 to 0.0
|
0.18 mg
Interval 0.0 to 5.0
|
|
Amount of Analgesic Use
Fentanyl
|
0.29 mg
Interval 0.0 to 0.55
|
0.37 mg
Interval 0.0 to 2.425
|
0.32 mg
Interval 0.0 to 2.575
|
|
Amount of Analgesic Use
Morphine
|
0 mg
Interval 0.0 to 0.0
|
0 mg
Interval 0.0 to 0.0
|
0.03 mg
Interval 0.0 to 1.5
|
|
Amount of Analgesic Use
Dilaudid
|
0 mg
Interval 0.0 to 0.0
|
0 mg
Interval 0.0 to 0.0
|
0.07 mg
Interval 0.0 to 4.0
|
SECONDARY outcome
Timeframe: During the Study Period (Study Days 0-7)Mean of sedative daily use (Propofol and Demedetomidine )
Outcome measures
| Measure |
Usual Care
n=2 Participants
Usual Care between 10pm-6am
|
Earplugs
n=3 Participants
Application of earplugs from 10pm-6am nightly for seven nights or until ICU discharge.
Foam Earplugs: Standard Foam Earplugs applied from 10pm-6am nightly. (Sperian Technologies, manufacturer)
|
Earplugs and Headphones
n=3 Participants
Earplugs and Noise-canceling headphones applied from 10pm-6am nightly for 7 nights or until ICU discharge.
Foam Earplugs: Standard Foam Earplugs applied from 10pm-6am nightly. (Sperian Technologies, manufacturer)
Noise Canceling Headphones: Noise Canceling headphones applied over the ears between 10pm-6am nightly. Model is Bose QuietComfort 15, manufactured by Bose Technologies.
|
|---|---|---|---|
|
Amount of Sedative Use (Propofol and Demedetomidine )
Propofol
|
0 mcg/kg
Interval 0.0 to 0.0
|
0 mcg/kg
Interval 0.0 to 0.0
|
0 mcg/kg
Interval 0.0 to 0.0
|
|
Amount of Sedative Use (Propofol and Demedetomidine )
Demedetomidine
|
1.36 mcg/kg
Interval 0.0 to 13.6
|
0.98 mcg/kg
Interval 0.0 to 9.9
|
0 mcg/kg
Interval 0.0 to 0.0
|
Adverse Events
Usual Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Earplugs
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Earplugs and Headphones
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place