The Effect of White Noise In High Noise Environment

Many patients complain to clinicians that they have difficulty sleeping appears to be due to environmental noise. There is a common perception that acute noises are more troublesome than continuous noises in the effect on individual sleep quality. Therefore the goal is to use a Marpac white noise maker with a continuous noise to see its effect on individuals that have difficulty sleeping in a high noise environment.

Study Overview

• Status: Completed
• Conditions: Insomnia
• Intervention / Treatment: Other: white noise

Detailed Description

Insomnia patients will be recruited based on their perception of high noise in their apartment. The investigators will screen patients during the first meeting using The Mini International Neuropsychiatric Interview 6.0 (MINI 6.0). At baseline, an Insomnia Severity Index will be administered.

The study will consist of a one week baseline period in which noise levels will be monitored using spectral analysis and decibel levels and sleep duration will be recorded using a subjective sleep log and wrist actigraphy for objective measurement. At the end of the first week an Insomnia Severity Index will be administered.

During the second week, a treatment period with a white noise machine using a fixed decibel level will be installed in the bedrooms of the subjects. The room noise will continue to be monitored via spectral analysis as well as decibel levels while the patients are wearing actigraphs and keeping a sleep log. At the end of the second week an Insomnia Severity Index will be administered.

During the third week, the white noise machine will be removed and the rooms will still be monitored for sound via spectral analysis and decibel levels and the subject will wear an actigraph and keep a sleep log. At the end of the third week an Insomnia Severity Index will be administered.

The investigators will use Analysis of Covariance (ANCOVA) with baseline vs. white noise to analyze differences. The investigators will use an Acute Noise Index, in which noise spikes of 2 standard deviations from the mean of the entire nights decibel levels count as a noise event.

Noise levels in subjects bedroom will be collected throughout the study along with subjects sleep activity using an actigraph and sleep log.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • Weill Cornell Medical College Center for Sleep

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Inclusion criteria for each participant are as follows: Must be between 18 and 100 years old
• No significant psychiatric conditions based on the The Mini International Neuropsychiatric Interview 6.0 (MINI 6.0)
• Not currently using narcotics, psychotropic or hypnotic medications and willing to refrain from using these medications during the course of the study
• Limits caffeine consumption to less than or equal to 2 coffee servings, or equivalent per day before 12 noon
• Limits alcohol intake to 7-drinks per week and less than or equal to 1 drinks on any one night
• Must adjust alcohol consumption to 7-drinks per week and less than or equal to 1 drink on any one night for at least two weeks before study begins, and must not consume alcohol later than 8pm
• Naps less than or equal to 1-hour per week according to subjective report
• For at least 3 times a week a minimum of 30 minute sleep latency or 30 minutes of total nighttime awakening due to subjective elevated noise.

Exclusion Criteria:

• Exclusion criteria for each participant are as follows: Younger than 18 years old or older than 100 years old
• Significant psychiatric conditions based on the The Mini International Neuropsychiatric Interview 6.0 (MINI 6.0)
• Currently using narcotics, psychotropic or hypnotic medications and not willing to refrain from using these medications during the course of the study
• Does not limit caffeine consumption to less than or equal to 2 coffee servings, or equivalent per day
• Does not limit alcohol intake to 7-drinks per week and less than or equal to 1 drinks on any one night , consumes alcohol later than 8pm
• Naps more than 1-hour per week according to subjective report
• Not at least 3 times a week at least 30 minute sleep latency or not 30 minutes of total nighttime awakening due to subjective elevated noise

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: White Noise; Subject will have white noise machine placed in room.	Other: white noise; exposure to white noise

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep Latency data using the actigraph	Subjects will have three weeks of sleep latency data using the actigraph and this data will be analyzed and presented.	Three weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep Latency data using sleep diaries	Subjects will have three weeks of sleep latency data using sleep diaries and this data will be analyzed and presented.	Three Weeks
Insomnia Severity Index	Subjects will complete an Insomnia Severity Index at the end of each of the three weeks of the study.	Three Weeks

Collaborators and Investigators

• Sponsor: Weill Medical College of Cornell University
• Collaborators: MARPAC

Study record dates

Study Major Dates

• Study Start: December 1, 2015
• Primary Completion (Actual): December 1, 2018
• Study Completion (Actual): December 1, 2018

Study Registration Dates

• First Submitted: December 8, 2015
• First Submitted That Met QC Criteria: January 5, 2016
• First Posted (Estimate): January 6, 2016

Study Record Updates

• Last Update Posted (Actual): June 17, 2019
• Last Update Submitted That Met QC Criteria: June 13, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 1502015935

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: There is no plan to make IPD available.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No