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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Background noise | Active Comparator | Overnight sleep study with filtered white noise |
|
| Silence | No Intervention | Overnight sleep study with normal environmental noise |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NIghtingale (R) device for filtered white noise (Cambridge Sound Management, Waltham, MA) | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sleep Onset Latency (Mins) | time from lights out to the first epoch of stage 2 NREM sleep | 1 night |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 1 night |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sleep Disorders Research Program Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Silence First, Background Noise Second |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Sleep Onset Latency (Mins) | time from lights out to the first epoch of stage 2 NREM sleep | Posted | Median | Inter-Quartile Range | minutes | 1 night |
|
|
2 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Background Noise | Overnight sleep study with filtered white noise (NIghtingale (R) Cambridge Sound Management, Waltham, MA) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Andrew Wellman | Brigham and women's Hospital | 6174078483 | awellman@rics.bwh.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Jan 26, 2018 | May 24, 2018 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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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) |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Participants |
|
|
|
| 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) | Posted | Median | Inter-Quartile Range | units on a scale | 1 night |
|
|
|
|
| 0 |
| 18 |
| 0 |
| 18 |
| 0 |
| 18 |
| EG001 | Silence | Overnight sleep study with normal environmental noise | 0 | 18 | 0 | 18 | 0 | 18 |
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| D001523 |
| Mental Disorders |