Trial Outcomes & Findings for Broadband Sound and Sleep (NCT NCT05774977)
NCT ID: NCT05774977
Last Updated: 2025-11-18
Results Overview
Combined time spent in sleep stages N3 and REM in minutes, as measured by polysomnography (PSG).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
27 participants
Primary outcome timeframe
Days 2-7
Results posted on
2025-11-18
Participant Flow
The study was designed to expose all subjects to the six noise conditions after an adaptation night. However, the order in which subjects experienced each condition varied, resulting in seven different condition sequences. Subjects were assigned to a study group with up to 4 total participants, where each participant experienced the same condition sequence. A total of 27 subjects were enrolled and assigned to one of the seven sequences.
Participant milestones
| Measure |
Noise Condition
This study uses within-subject comparison. For each subject, the order of noise conditions for each of the six nights following an adaptation night will be randomized. All subjects will receive all noise conditions.
Please refer to the study design and protocol for additional information.
A. Pink noise, 50 dBA only (BN50): The BN50 night consisted of exposure to continuous pink noise throughout the sleep period at a level of 50 A-weighted decibels (dBA).
B. Aviation noise plus pink noise 50 dBA (AN+BN50): The AN + BN50 night consisted of the aviation noise (AN) exposure with the addition of continuous pink noise throughout the sleep period at a level of 50 dBA.
C. Control night (CTRL) without noise exposure and without earplugs.
D. Aviation noise plus pink noise 40 dBA (AN+BN40): The AN + BN40 night will consist of the aviation noise (AN) exposure with the addition of continuous pink noise throughout the sleep period at a level of 40 dBA.
E. Aviation Noise Only (AN): The aviation noise (AN) exposure was a pre-programmed recording of 93 sounds, including aviation-related noises (e.g. helicopter, sonic boom) and alerting noise (alarm, baby crying) with a range between 45 dB to 65 dB, played during sleep from 2300-0700.
F. Aviation noise plus earplugs (AN+EP): The AN + EP night consist of the aviation noise (AN) exposure with the addition of wearing earplugs during the sleep period.
|
|---|---|
|
Overall Study
STARTED
|
27
|
|
Overall Study
Pink Noise, 50 dBA (BN50)
|
25
|
|
Overall Study
Aviation Noise Plus Pink Noise 50 dBA (AN+BN50)
|
24
|
|
Overall Study
Control Night (CTRL)
|
21
|
|
Overall Study
Aviation Noise Plus Pink Noise 40 dBA (AN+BN40)
|
24
|
|
Overall Study
Aviation Noise Only (AN)
|
25
|
|
Overall Study
Aviation Noise Plus Earplugs (AN+EP)
|
25
|
|
Overall Study
COMPLETED
|
25
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Noise Condition
This study uses within-subject comparison. For each subject, the order of noise conditions for each of the six nights following an adaptation night will be randomized. All subjects will receive all noise conditions.
Please refer to the study design and protocol for additional information.
A. Pink noise, 50 dBA only (BN50): The BN50 night consisted of exposure to continuous pink noise throughout the sleep period at a level of 50 A-weighted decibels (dBA).
B. Aviation noise plus pink noise 50 dBA (AN+BN50): The AN + BN50 night consisted of the aviation noise (AN) exposure with the addition of continuous pink noise throughout the sleep period at a level of 50 dBA.
C. Control night (CTRL) without noise exposure and without earplugs.
D. Aviation noise plus pink noise 40 dBA (AN+BN40): The AN + BN40 night will consist of the aviation noise (AN) exposure with the addition of continuous pink noise throughout the sleep period at a level of 40 dBA.
E. Aviation Noise Only (AN): The aviation noise (AN) exposure was a pre-programmed recording of 93 sounds, including aviation-related noises (e.g. helicopter, sonic boom) and alerting noise (alarm, baby crying) with a range between 45 dB to 65 dB, played during sleep from 2300-0700.
F. Aviation noise plus earplugs (AN+EP): The AN + EP night consist of the aviation noise (AN) exposure with the addition of wearing earplugs during the sleep period.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
Baseline Characteristics
One subject withdrew from Group 2 and was excluded from analysis. One subject withdrew from Group 7 and was excluded from analysis.
Baseline characteristics by cohort
| Measure |
Group 1: A B C D E F
n=4 Participants
Subjects in Group 1 experienced the conditions in this order: A B C D E F.
|
Group 2: B D A F C E
n=4 Participants
Subjects in Group 2 experienced the conditions in this order: B D A F C E.
|
Group 3: C A E B C D
n=4 Participants
Subjects in Group 3 were scheduled to experience the conditions in this order: C A E B F D. However, the PSG system failed in three out of four subjects in study night 2. Therefore, it was decided by the PI to rerun the night 2 exposure (condition C) on night 6. In doing so, the condition originally planned for night 6 (condition F) was removed from this study sequence, and Group 3 subjects did not experience the condition F exposure.
|
Group 4: D F B E A C
n=3 Participants
Subjects in Group 4 experienced the conditions in this order: D F B E A C.
|
Group 5: E C F B D A
n=4 Participants
Subjects in Group 5 were scheduled to experience the conditions in this order: E C F A D B. However, due to an inadvertent selection of the audio sequence on night 5, the file for night 7 was played on night 5. Therefore, the noise conditions originally planned for night 5 and 7 were switched in order to expose subjects to all noise conditions.
|
Group 6: F E D C B A
n=4 Participants
Subjects in Group 6 experienced the conditions in this order: F E D C B A.
|
Group 7: C D E A F B
n=4 Participants
Subjects in Group 7 experienced the conditions in this order: C D E A F B.
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
24.25 years
STANDARD_DEVIATION 1.71 • n=4 Participants • One subject withdrew from Group 2 and was excluded from analysis. One subject withdrew from Group 7 and was excluded from analysis.
|
30 years
STANDARD_DEVIATION 9.85 • n=3 Participants • One subject withdrew from Group 2 and was excluded from analysis. One subject withdrew from Group 7 and was excluded from analysis.
|
30 years
STANDARD_DEVIATION 2.94 • n=4 Participants • One subject withdrew from Group 2 and was excluded from analysis. One subject withdrew from Group 7 and was excluded from analysis.
|
26 years
STANDARD_DEVIATION 4.36 • n=3 Participants • One subject withdrew from Group 2 and was excluded from analysis. One subject withdrew from Group 7 and was excluded from analysis.
|
28.75 years
STANDARD_DEVIATION 6.55 • n=4 Participants • One subject withdrew from Group 2 and was excluded from analysis. One subject withdrew from Group 7 and was excluded from analysis.
|
28.5 years
STANDARD_DEVIATION 7.85 • n=4 Participants • One subject withdrew from Group 2 and was excluded from analysis. One subject withdrew from Group 7 and was excluded from analysis.
|
33 years
STANDARD_DEVIATION 6.56 • n=3 Participants • One subject withdrew from Group 2 and was excluded from analysis. One subject withdrew from Group 7 and was excluded from analysis.
|
28.54 years
STANDARD_DEVIATION 5.89 • n=25 Participants • One subject withdrew from Group 2 and was excluded from analysis. One subject withdrew from Group 7 and was excluded from analysis.
|
|
Race (NIH/OMB)
White
|
1 Participants
n=4 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=4 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=3 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=4 Participants
|
19 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=4 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=3 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=3 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=4 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=4 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=3 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=4 Participants
|
4 participants
n=4 Participants
|
4 participants
n=4 Participants
|
3 participants
n=3 Participants
|
4 participants
n=4 Participants
|
4 participants
n=4 Participants
|
4 participants
n=4 Participants
|
27 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Days 2-7Combined time spent in sleep stages N3 and REM in minutes, as measured by polysomnography (PSG).
Outcome measures
| Measure |
Aviation Noise Only
n=25 Participants
Aviation Noise Only (AN): The aviation noise (AN) night will expose subjects to a pre-programmed recording of aviation noise during sleep from 2300-0700.
|
Pink Noise Only (50 dBA)
n=25 Participants
Pink noise, 50 dBA only (BN50): The BN50 night will consist of exposure to continuous pink noise throughout the sleep period at a level of 50 A-weighted decibels (dBA).
|
Aviation Noise With Earplugs
n=21 Participants
Aviation noise plus earplugs (AN+EP): The AN + EP night will consist of the aviation noise (AN) exposure with the addition of wearing earplugs overnight.
|
Aviation Noise With Pink Noise, 40 dBA
n=24 Participants
Aviation noise plus white noise 40 dBA (AN+BN40): The AN + BN40 night will consist of the aviation noise (AN) exposure with the addition of continuous pink noise throughout the sleep period at a level of 40 dBA.
|
Aviation Noise With Pink Noise, 50 dBA
n=24 Participants
Aviation noise plus white noise 50 dBA (AN+BN50): The AN + BN50 night will consist of the aviation noise (AN) exposure with the addition of continuous pink noise throughout the sleep period at a level of 50 dBA.
|
Control
n=25 Participants
Control Night (CTRL): Control night (CTRL) without noise exposure and without earplugs.
|
|---|---|---|---|---|---|---|
|
Time Spent in Slow Wave Sleep and Rapid Eye Movement (N3 + REM)
|
188.5532184 Minutes
Interval 172.8271298 to 204.279307
|
195.9798771 Minutes
Interval 180.1286092 to 211.831145
|
209.51862074703 Minutes
Interval 193.2405983 to 225.7966432
|
176.4599674 Minutes
Interval 160.6090035 to 192.3109313
|
174.2895997 Minutes
Interval 158.4417133 to 190.1374861
|
219.0943443 Minutes
Interval 203.4591503 to 234.7295384
|
SECONDARY outcome
Timeframe: Days 2-7Efficiency scores from 10 brief cognitive tasks are generated from accuracy \& speed of reaction/responding, represented here by standardized effect sizes, where higher scores indicate better performance. Test scores were adjusted for practice and stimulus set effects, and z-transformed based on average and standard deviation across all tests taken. Accuracy and speed across cognitive domains were calculated by averaging z-scores across the 10 tests, then averaged to calculate an efficiency metric. Scores between -0.2 and +0.2 suggest no effect on efficiency (0=population mean). Between -0.2 and -0.5 suggests a small negative effect (i.e. slightly less efficient). Between -0.5 and -0.8 suggests a moderate negative effect. Scores below -0.8 suggest a large negative effect. Between 0.2 and 0.5 suggests a small positive effect. Between 0.5 and 0.8 suggests a moderate positive effect. Scores above 0.8 suggest a large positive effect (i.e. significantly more efficient).
Outcome measures
| Measure |
Aviation Noise Only
n=25 Participants
Aviation Noise Only (AN): The aviation noise (AN) night will expose subjects to a pre-programmed recording of aviation noise during sleep from 2300-0700.
|
Pink Noise Only (50 dBA)
n=25 Participants
Pink noise, 50 dBA only (BN50): The BN50 night will consist of exposure to continuous pink noise throughout the sleep period at a level of 50 A-weighted decibels (dBA).
|
Aviation Noise With Earplugs
n=21 Participants
Aviation noise plus earplugs (AN+EP): The AN + EP night will consist of the aviation noise (AN) exposure with the addition of wearing earplugs overnight.
|
Aviation Noise With Pink Noise, 40 dBA
n=24 Participants
Aviation noise plus white noise 40 dBA (AN+BN40): The AN + BN40 night will consist of the aviation noise (AN) exposure with the addition of continuous pink noise throughout the sleep period at a level of 40 dBA.
|
Aviation Noise With Pink Noise, 50 dBA
n=24 Participants
Aviation noise plus white noise 50 dBA (AN+BN50): The AN + BN50 night will consist of the aviation noise (AN) exposure with the addition of continuous pink noise throughout the sleep period at a level of 50 dBA.
|
Control
n=25 Participants
Control Night (CTRL): Control night (CTRL) without noise exposure and without earplugs.
|
|---|---|---|---|---|---|---|
|
Cognition Efficiency
|
-0.064223254075 Z-score
Standard Error 0.065476995
|
-0.080820342 Z-score
Standard Error 0.065961006
|
-0.002037537 Z-score
Standard Error 0.067457746
|
-0.005021343 Z-score
Standard Error 0.065934126
|
-0.02031753 Z-score
Standard Error 0.065473068
|
-0.061364516 Z-score
Standard Error 0.064361916
|
SECONDARY outcome
Timeframe: Days 2-7A single variable representing response time across 10 Cognitive tasks that cover a range of cognitive domains with known cerebral representation. Test scores were adjusted for practice and stimulus set effects, and z-transformed based on average and standard deviation across all tests taken. Speed across cognitive domains was calculated by averaging z-scores across the 10 tests. Higher scores reflect faster speed. Scores between -0.2 and +0.2 suggest no effect on speed (0=population mean). Between -0.2 and -0.5 suggests a small negative effect (i.e. slightly slower). Between -0.5 and -0.8 suggests a moderate negative effect. Scores below -0.8 suggest a large negative effect (i.e. significantly slower). Between 0.2 and 0.5 suggests a small positive effect (i.e. slightly faster). Between 0.5 and 0.8 suggests a moderate positive effect. Scores above 0.8 suggest a large positive effect (i.e. significantly faster).
Outcome measures
| Measure |
Aviation Noise Only
n=25 Participants
Aviation Noise Only (AN): The aviation noise (AN) night will expose subjects to a pre-programmed recording of aviation noise during sleep from 2300-0700.
|
Pink Noise Only (50 dBA)
n=25 Participants
Pink noise, 50 dBA only (BN50): The BN50 night will consist of exposure to continuous pink noise throughout the sleep period at a level of 50 A-weighted decibels (dBA).
|
Aviation Noise With Earplugs
n=21 Participants
Aviation noise plus earplugs (AN+EP): The AN + EP night will consist of the aviation noise (AN) exposure with the addition of wearing earplugs overnight.
|
Aviation Noise With Pink Noise, 40 dBA
n=24 Participants
Aviation noise plus white noise 40 dBA (AN+BN40): The AN + BN40 night will consist of the aviation noise (AN) exposure with the addition of continuous pink noise throughout the sleep period at a level of 40 dBA.
|
Aviation Noise With Pink Noise, 50 dBA
n=24 Participants
Aviation noise plus white noise 50 dBA (AN+BN50): The AN + BN50 night will consist of the aviation noise (AN) exposure with the addition of continuous pink noise throughout the sleep period at a level of 50 dBA.
|
Control
n=25 Participants
Control Night (CTRL): Control night (CTRL) without noise exposure and without earplugs.
|
|---|---|---|---|---|---|---|
|
Cognition Speed
|
-0.133247423 z-score
Standard Error 0.115983876
|
-0.144315479 z-score
Standard Error 0.116338083
|
-0.057069789 z-score
Standard Error 0.117437672
|
-0.056543403 z-score
Standard Error 0.116319131
|
-0.078872577 z-score
Standard Error 0.115981035
|
-0.08897121 z-score
Standard Error 0.115186663
|
SECONDARY outcome
Timeframe: Days 2-7A single variable representing response time across 10 Cognitive tasks that cover a range of cognitive domains with known cerebral representation. Test scores were adjusted for practice and stimulus set effects, and z-transformed based on average and standard deviation across all tests taken. Accuracy across cognitive domains was calculated by averaging z-scores across the 10 tests. Higher scores reflect better accuracy. Scores between -0.2 and +0.2 suggest no effect on accuracy (0=population mean). Between -0.2 and -0.5 suggests a small negative effect (i.e. slightly less accurate). Between -0.5 and -0.8 suggests a moderate negative effect. Scores below -0.8 suggest a large negative effect (i.e. significantly less accurate). Between 0.2 and 0.5 suggests a small positive effect (i.e. slightly more accurate). Between 0.5 and 0.8 suggests a moderate positive effect. Scores above 0.8 suggest a large positive effect (i.e. significantly more accurate).
Outcome measures
| Measure |
Aviation Noise Only
n=25 Participants
Aviation Noise Only (AN): The aviation noise (AN) night will expose subjects to a pre-programmed recording of aviation noise during sleep from 2300-0700.
|
Pink Noise Only (50 dBA)
n=25 Participants
Pink noise, 50 dBA only (BN50): The BN50 night will consist of exposure to continuous pink noise throughout the sleep period at a level of 50 A-weighted decibels (dBA).
|
Aviation Noise With Earplugs
n=21 Participants
Aviation noise plus earplugs (AN+EP): The AN + EP night will consist of the aviation noise (AN) exposure with the addition of wearing earplugs overnight.
|
Aviation Noise With Pink Noise, 40 dBA
n=24 Participants
Aviation noise plus white noise 40 dBA (AN+BN40): The AN + BN40 night will consist of the aviation noise (AN) exposure with the addition of continuous pink noise throughout the sleep period at a level of 40 dBA.
|
Aviation Noise With Pink Noise, 50 dBA
n=24 Participants
Aviation noise plus white noise 50 dBA (AN+BN50): The AN + BN50 night will consist of the aviation noise (AN) exposure with the addition of continuous pink noise throughout the sleep period at a level of 50 dBA.
|
Control
n=25 Participants
Control Night (CTRL): Control night (CTRL) without noise exposure and without earplugs.
|
|---|---|---|---|---|---|---|
|
Cognition Accuracy
|
0.004818355 z-score
Standard Error 0.082094556
|
-0.016730648 z-score
Standard Error 0.082952084
|
0.055614609 z-score
Standard Error 0.085599407
|
0.04713328 z-score
Standard Error 0.082902765
|
0.038223035 z-score
Standard Error 0.082087524
|
-0.035636712 z-score
Standard Error 0.080077528
|
SECONDARY outcome
Timeframe: Days 2-7The standard deviation of lane position reflects the extent (in feet) to which participants "swerve" within the lane in a virtual driving simulator, often used to investigate the effects of impairment on driving performance, where higher values represent worse performance.
Outcome measures
| Measure |
Aviation Noise Only
n=25 Participants
Aviation Noise Only (AN): The aviation noise (AN) night will expose subjects to a pre-programmed recording of aviation noise during sleep from 2300-0700.
|
Pink Noise Only (50 dBA)
n=25 Participants
Pink noise, 50 dBA only (BN50): The BN50 night will consist of exposure to continuous pink noise throughout the sleep period at a level of 50 A-weighted decibels (dBA).
|
Aviation Noise With Earplugs
n=21 Participants
Aviation noise plus earplugs (AN+EP): The AN + EP night will consist of the aviation noise (AN) exposure with the addition of wearing earplugs overnight.
|
Aviation Noise With Pink Noise, 40 dBA
n=24 Participants
Aviation noise plus white noise 40 dBA (AN+BN40): The AN + BN40 night will consist of the aviation noise (AN) exposure with the addition of continuous pink noise throughout the sleep period at a level of 40 dBA.
|
Aviation Noise With Pink Noise, 50 dBA
n=24 Participants
Aviation noise plus white noise 50 dBA (AN+BN50): The AN + BN50 night will consist of the aviation noise (AN) exposure with the addition of continuous pink noise throughout the sleep period at a level of 50 dBA.
|
Control
n=25 Participants
Control Night (CTRL): Control night (CTRL) without noise exposure and without earplugs.
|
|---|---|---|---|---|---|---|
|
Driving Simulator Standard Deviation of Lane Position
|
1.40658463 feet
Standard Deviation 0.088697515
|
1.394516627 feet
Standard Deviation 0.08888539
|
1.340740078 feet
Standard Deviation 0.089469215
|
1.425292912 feet
Standard Deviation 0.088875405
|
1.359432551 feet
Standard Deviation 0.088696012
|
1.377041493 feet
Standard Deviation 0.08827651
|
Adverse Events
Group 1: A B C D E F
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 2: B D A F C E
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 3: C A E B C D
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 4: D F B E A C
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 5: E C F B D A
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 6: F E D C B A
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 7: C D E A F B
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
Dr. Mathias Basner, MD, PhD, MScEpi
University of Pennsylvania Perelman School of Medicine
Phone: 215-573-5866
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place