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NCT02945254 · ClinicalTrials.gov registry record · Phase 1
Effect of Background Noise on Sleep Quality
A Phase 1 study of Sleep Onset Insomnia, sponsored by Brigham and Women's Hospital.
- Completed
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT02945254: Completed Phase 1 study of Sleep Onset Insomnia, sponsored by Brigham and Women's Hospital.
NCT02945254 is a Phase 1 study of Sleep Onset Insomnia that has completed, run by Brigham and Women's Hospital. The registered enrollment target is 20 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02945254, a Phase 1 study of Sleep Onset Insomnia, has completed, sponsored by Brigham and Women's Hospital.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
time from lights out to the first epoch of stage 2 NREM sleep
Conditions Studied
Interventions
- DEVICE NIghtingale (R) device for filtered white noise (Cambridge Sound Management, Waltham, MA)
Study Locations (1)
Massachusetts
- Sleep Disorders Research Program Brigham and Women's Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2016-08 |
| Est. Completion | 2017-02 |
| Phase | Phase 1 |
What the finished NCT02945254 record still lists
NCT02945254 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower).
The record links to 1 condition, with Sleep Onset Insomnia appearing as the primary indexed condition, and to 1 intervention - of which NIghtingale (R) device for filtered white noise (Cambridge Sound Management, Waltham, MA) is the first listed.
NCT02945254 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT02945254 about?
NCT02945254 is a clinical study titled "Effect of Background Noise on Sleep Quality". 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, diab...
What is the current status of trial NCT02945254?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2016-08. Estimated completion is 2017-02.
What conditions does trial NCT02945254 study?
This clinical trial studies the following conditions: Sleep Onset Insomnia.
What interventions are being tested in trial NCT02945254?
The interventions under investigation include: NIghtingale (R) device for filtered white noise (Cambridge Sound Management, Waltham, MA) (DEVICE).
Who is sponsoring clinical trial NCT02945254?
This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02945254 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02945254's enrollment target sits among peer trials
20 1629th of 2000 higher than 285 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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