InsomniaNCT02647138
The Effect of White Noise In High Noise Environment
A study testing white noise in people with Insomnia, run by Weill Medical College of Cornell University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Insomnia
- What is being tested?
- white noise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2015to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Weill Cornell Medical College Center for Sleep
New York, New York, 10065
About this study
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.
Read the 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.
- Conditions
- Insomnia
- Being tested
- white noise
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
white noiseOther
exposure to white noise
| Study group | Role | What they receive |
|---|---|---|
| White Noise | Experimental | Subject will have white noise machine placed in room. Receives: Other: white noise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Three weeks
Secondary outcomes (2)
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.
Measured: Three Weeks
Insomnia Severity Index
Subjects will complete an Insomnia Severity Index at the end of each of the three weeks of the study.
Measured: Three Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2016 (estimated)
- Study startDec 2015
- Primary completionDec 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- MARPAC
- Responsible party
- Sponsor
- Investigators
- Ana C Krieger, MD, MPH, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02647138
- Sponsor's protocol ID
- 1502015935
- Status last verified
- Jun 2019
- First submitted
- 8 Dec 2015
- Last updated
- 17 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make IPD available.
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of White Noise In High Noise Environment
- ClinicalTrials.gov ID
- NCT02647138
- Acronym / sponsor ID
- 1502015935
- Conditions
- Insomnia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- MARPAC
- Study start
- Dec 2015
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 6 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| White Noise | Experimental | Other: white noiseSubject will have white noise machine placed in room. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| white noiseexposure to white noise | Other | White Noise |
Primary outcome
Sleep Latency data using the actigraph
Time frame: Three weeks
Subjects will have three weeks of sleep latency data using the actigraph and this data will be analyzed and presented.
2 secondary outcomes
Sleep Latency data using sleep diaries
Time frame: Three Weeks
Insomnia Severity Index
Time frame: Three Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2019.
- Individual participant dataSharing planned: No. There is no plan to make IPD available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ana C Krieger, MD, MPH principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing white noise in people with Insomnia, run by Weill Medical College of Cornell University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep Latency data using the actigraph (time frame: Three weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2019.