CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 20 enrolled
Drug / intervention
NIghtingale (R) device for filtered white noise (Cambridge Sound Management, Waltham, MA)device
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02945254
NCT02945254Phase 2Completed

Effect of Continuous Background Noise at Specific Frequencies on Objective and Subjective Sleep Quality

Brigham and Women's Hospital·interventional·Posted Oct 26, 2016·Updated May 25, 2018

In Brief

A Phase 2 clinical trial evaluating NIghtingale (R) device for filtered white noise (Cambridge Sound Management, Waltham, MA) for Sleep Onset Insomnia. Completed, enrolled 20 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedOct 26, 2016
Enrollment StartAug 1, 2016
Primary CompletionFeb 1, 2017
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 9.7 years ago

Interventions

NIghtingale (R) device for filtered white noise (Cambridge Sound Management, Waltham, MA)device