The Effect of White Noise In High Noise Environment

NCT02647138 | Completed

• 1 other identifier: 1502015935
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Insomnia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Sleep Latency data using sleep diaries

  Three Weeks

• Insomnia Severity Index

  Three Weeks

Study Arms (1)

White Noise

EXPERIMENTAL

Subject will have white noise machine placed in room.

Other: white noise

Interventions

white noise OTHER

exposure to white noise

White Noise

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• MARPAC: collaborator

Study Sites (1)

Weill Cornell Medical College Center for Sleep

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Ana C Krieger, MD, MPH

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2015
• First Posted: January 6, 2016
• Study Start: December 1, 2015
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: June 17, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)