Phase 2
N=20
Effect of Background Noise on Sleep Quality
Sleep Onset Insomnia
Bottom Line
View on ClinicalTrials.gov: NCT02945254 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
May 2018
Primary outcome: Primary: Sleep Onset Latency (Mins) — 13; 19 minutes — p=0.011
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- NIghtingale (R) device for filtered white noise (Cambridge Sound Management, Waltham, MA) (Device)
- Age
- Adult · 21+ yrs
- Sex
- All
- Sponsor
- Brigham and Women's Hospital
- Primary completion
- Feb 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sleep Onset Latency (Mins) |
13; 19 | 0.011 sig |
| SECONDARY Subjective Sleep Quality (VAS) |
7; 7 | 0.13 |
Summary
Insufficient and low-quality sleep is a major public health problem that has been linked to motor vehicle crashes, industrial disasters, and medical and other occupational errors. Persons experiencing sleep insufficiency are also more likely to suffer from chronic diseases such as hypertension, diabetes, depression, and obesity, as well as from cancer, increased mortality, and reduced quality of life and productivity.
The number of people using sleep-inducing drugs to increase or improve sleep is steadily increasing in the last few decades; however, the side effects of these therapies often outweigh the benefits.
A few small trials and anecdotal findings suggest that continuous background (pink or white) noise overnight can improve sleep quality, increase acoustic arousal threshold, and reduce sleep onset latency.
In an attempt to find new, alternative solutions to increase sleep quality in people suffering from insomnia, the investigators would like to test the effect of surrounding filtered white noise on sleep onset latency and subjective sleep quality in healthy subjects.
Eligibility Criteria
Inclusion Criteria
- Age between 21 and 60
Exclusion Criteria
- Any sleep disorder
- Use of hypnotics
Data sourced from ClinicalTrials.gov (NCT02945254). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.