Effect of Background Noise on Sleep Quality

Mass General Brigham

Status and phase: Completed; Phase 2; Phase 1

Conditions: Sleep Onset Insomnia

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02945254

2016P000982

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 21 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age between 21 and 60

Exclusion criteria

• Any sleep disorder
• Use of hypnotics

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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20 participants in 2 patient groups

Background noise

Active Comparator group

Description:

Overnight sleep study with filtered white noise

Treatment:

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

Silence

No Intervention group

Description:

Overnight sleep study with normal environmental noise