Trial Outcomes & Findings for Effect of Background Noise on Sleep Quality (NCT NCT02945254)

NCT ID: NCT02945254

Last Updated: 2018-05-25

Results Overview

time from lights out to the first epoch of stage 2 NREM sleep

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 20 participants
• Primary outcome timeframe: 1 night
• Results posted on: 2018-05-25

Participant Flow

Participant milestones

Measure	Background Noise First, Silence Second Overnight sleep study with filtered white noise (Nightingale (R) device, Cambridge Sound Management, Waltham, MA) on the first study night, then a 1-week non-treatment period, then Overnight sleep study with normal environmental noise	Silence First, Background Noise Second Overnight sleep study with normal environmental noise, then a 1-week non-treatment period, then an Overnight sleep study with filtered white noise (Nightingale (R), Cambridge Sound Management, Waltham, MA)
Overall Study STARTED	10	10
Overall Study COMPLETED	8	10
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Measure	Background Noise First, Silence Second Overnight sleep study with filtered white noise (Nightingale (R) device, Cambridge Sound Management, Waltham, MA) on the first study night, then a 1-week non-treatment period, then Overnight sleep study with normal environmental noise	Silence First, Background Noise Second Overnight sleep study with normal environmental noise, then a 1-week non-treatment period, then an Overnight sleep study with filtered white noise (Nightingale (R), Cambridge Sound Management, Waltham, MA)
Overall Study Lost to Follow-up	1	0
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

Effect of Background Noise on Sleep Quality

Baseline characteristics by cohort

Measure	Background Noise First, Silence Second n=8 Participants Overnight sleep study with filtered white noise (Nightingale (R) device, Cambridge Sound Management, Waltham, MA) on the first study night, then a 1-week non-treatment period, then Overnight sleep study with normal environmental noise	Silence First, Background Noise Second n=10 Participants Overnight sleep study with normal environmental noise, then a 1-week non-treatment period, then an Overnight sleep study with filtered white noise (Nightingale (R), Cambridge Sound Management, Waltham, MA)	Total n=18 Participants Total of all reporting groups
Age, Continuous	28.5 years STANDARD_DEVIATION 9.1 • n=5 Participants	31.6 years STANDARD_DEVIATION 10.4 • n=7 Participants	30.2 years STANDARD_DEVIATION 9.7 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	7 Participants n=7 Participants	9 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	3 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	7 Participants n=5 Participants	8 Participants n=7 Participants	15 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 night

time from lights out to the first epoch of stage 2 NREM sleep

Outcome measures

Measure	Background Noise n=18 Participants Overnight sleep study with filtered white noise (NIghtingale (R) Cambridge Sound Management, Waltham, MA)	Silence n=18 Participants Overnight sleep study with normal environmental noise
Sleep Onset Latency (Mins)	13 minutes Interval 5.0 to 31.0	19 minutes Interval 12.0 to 28.0

SECONDARY outcome

Timeframe: 1 night

subjective sleep quality was assessed in the morning with a visual analog scale (VAS) ranging from 1 (worse quality) to 10 (best quality)

Outcome measures

Measure	Background Noise n=18 Participants Overnight sleep study with filtered white noise (NIghtingale (R) Cambridge Sound Management, Waltham, MA)	Silence n=18 Participants Overnight sleep study with normal environmental noise
Subjective Sleep Quality (VAS)	7 units on a scale Interval 4.7 to 7.3	7 units on a scale Interval 6.8 to 8.3

Adverse Events

Background Noise

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Silence

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

Andrew Wellman

Brigham and women's Hospital

Phone: 6174078483

Email: awellman@rics.bwh.harvard.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place