Sleep Onset Insomnia
Conditions
Keywords
sleep onset latency, sleep quality, insomnia
Brief 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.
Interventions
DEVICENIghtingale (R) device for filtered white noise (Cambridge Sound Management, Waltham, MA)
Sponsors
Brigham and Women's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Age between 21 and 60
Exclusion criteria
* Any sleep disorder * Use of hypnotics
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sleep Onset Latency (Mins) | 1 night | time from lights out to the first epoch of stage 2 NREM sleep |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subjective Sleep Quality (VAS) | 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) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 8 |
| 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) | 10 |
| Total | 18 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Silence First, Background Noise Second | Total | Background Noise First, Silence Second |
|---|---|---|---|
| Age, Continuous | 31.6 years STANDARD_DEVIATION 10.4 | 30.2 years STANDARD_DEVIATION 9.7 | 28.5 years STANDARD_DEVIATION 9.1 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 8 Participants | 15 Participants | 7 Participants |
| Sex: Female, Male Female | 7 Participants | 9 Participants | 2 Participants |
| Sex: Female, Male Male | 3 Participants | 9 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 18 | 0 / 18 |
| other Total, other adverse events | 0 / 18 | 0 / 18 |
| serious Total, serious adverse events | 0 / 18 | 0 / 18 |
Outcome results
Primary
Sleep Onset Latency (Mins)
time from lights out to the first epoch of stage 2 NREM sleep
Time frame: 1 night
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Background Noise | Sleep Onset Latency (Mins) | 13 minutes |
| Silence | Sleep Onset Latency (Mins) | 19 minutes |
p-value: 0.011Wilcoxon (Mann-Whitney)
Secondary
Subjective Sleep Quality (VAS)
subjective sleep quality was assessed in the morning with a visual analog scale (VAS) ranging from 1 (worse quality) to 10 (best quality)
Time frame: 1 night
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Background Noise | Subjective Sleep Quality (VAS) | 7 units on a scale |
| Silence | Subjective Sleep Quality (VAS) | 7 units on a scale |
p-value: 0.13Wilcoxon (Mann-Whitney)