Study of Nasal Airflow Pressure Optimization to Resolve Excessive Snoring (SNORE)
Primary Purpose
Snoring
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
nasal continuous positive airway pressure less than or equal to 6 cm H2O
Sponsored by
About this trial
This is an interventional treatment trial for Snoring
Eligibility Criteria
Inclusion Criteria:
- Subject is > 18 years of age.
- Subject is willing and able to provide written Informed Consent using a Patient Information and Consent form that has been reviewed and approved by a governing Institutional Review Board (IRB).
- Subject has a history of habitual snoring (almost every night or every night for at least 30% of the night) as determined by the subject or a bed-partner.
- Subject has been pre-screened and demonstrates no excess daytime sleepiness on an Epworth Questionnaire (an assessment of daytime sleepiness; high number = greater sleepiness) score of less than 11, no history of witnessed apneas or nocturnal gasping/choking episodes and a body mass index (BMI) ≤ 35.
Inclusion Criteria for treatment trials (Nights 2 and 3):
- Subject meets Inclusion Criteria for the Baseline Trial (criteria a-d above)
- The subject has snoring intensity that exceeds 40 dBA during ≥30% of the respiratory efforts during sleep time on the baseline study night.
Exclusion Criteria:
- Subject has been diagnosed with COPD (Chronic Obstructive Pulmonary Disease), such as asthma, emphysema or chronic bronchitis.
- Subject has a history of heart disease, heart attack or stroke.
- Subject has uncontrolled or poorly controlled hypertension.
- Subject has been diagnosed with Obstructive Sleep Apnea (OSA), defined as an apnea hypopnea index (AHI) ≥ 5/hr in the presence of excessive sleepiness (an Epworth score ≥ 11) or AHI ≥15/hr when there is no evidence of excessive daytime sleepiness (an Epworth score ≤ 10).
- Subject is currently participating in another clinical study for which follow-up is ongoing.
Sites / Locations
- NeuroTrials Research, Inc.
- Johns Hopkins Bayview Medical Center
- Doctors Community Hospital
Outcomes
Primary Outcome Measures
Efficacy - The Cloud9™ device is expected to reduce the incidence of snoring.
The primary objective of this study is to demonstrate that minimally effective nasal CPAP (≤ 6 cm H2O) delivered by the Cloud9™ device reduces the number of snoring events and reduces snoring intensity in habitual, simple snorers in treatment session 3. We will test the hypothesis that the Cloud9™ device will decrease the number of loud snores by 50% or decrease the overall number of snores by 50%.
Secondary Outcome Measures
Safety - Adverse events associated with CPAP (nasal or skin irritation, epistaxis and sleep disruption) will occur in few subjects.
Safety- Adverse events associated with the Cloud9™ device (nasal or skin irritation, epistaxis and sleep disruption) will occur in fewer than 20% of the subjects in this study.
Full Information
NCT ID
NCT01949584
First Posted
September 20, 2013
Last Updated
March 23, 2015
Sponsor
inSleep Technologies, LLC
Collaborators
Johns Hopkins University, Doctors Community Hospital, NeuroTrials Research, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01949584
Brief Title
Study of Nasal Airflow Pressure Optimization to Resolve Excessive Snoring
Acronym
SNORE
Official Title
Study of Nasal Airflow Pressure Optimization to Resolve Excessive Snoring
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
inSleep Technologies, LLC
Collaborators
Johns Hopkins University, Doctors Community Hospital, NeuroTrials Research, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a prospective, interventional, study in which patients with a history of habitual snoring to determine whether low pressure nasal continuous airway pressure can reduce the frequency, duration or intensity of snoring in subjects with mild to moderate snoring who do not have Obstructive Sleep Apnea (OSA).
Detailed Description
In this a prospective, interventional, study, each patient will be studied four times. Subjects without OSA will undergo an initial observational control study to establish the presence of snoring (session 1); a single CPAP titration night to determine the minimally effective CPAP level (session 2) to alleviate snoring; a subsequent full night of CPAP treatment at this CPAP level (CPAP not to exceed 6 cm H2O) using the Cloud9™ low-pressure CPAP device (session 3); and a final control night of study conducted off CPAP to assess whether the patient's snoring remained stable over time (session 4). In this study, each subject shall serve as his/her own control.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Snoring
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
nasal continuous positive airway pressure less than or equal to 6 cm H2O
Other Intervention Name(s)
Cloud9™ nasal CPAP device and nasal interface
Intervention Description
Low level continuous positive airway pressure delivered during sleep.
Primary Outcome Measure Information:
Title
Efficacy - The Cloud9™ device is expected to reduce the incidence of snoring.
Description
The primary objective of this study is to demonstrate that minimally effective nasal CPAP (≤ 6 cm H2O) delivered by the Cloud9™ device reduces the number of snoring events and reduces snoring intensity in habitual, simple snorers in treatment session 3. We will test the hypothesis that the Cloud9™ device will decrease the number of loud snores by 50% or decrease the overall number of snores by 50%.
Time Frame
single night of sleep
Secondary Outcome Measure Information:
Title
Safety - Adverse events associated with CPAP (nasal or skin irritation, epistaxis and sleep disruption) will occur in few subjects.
Description
Safety- Adverse events associated with the Cloud9™ device (nasal or skin irritation, epistaxis and sleep disruption) will occur in fewer than 20% of the subjects in this study.
Time Frame
two different single nights
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Subject is > 18 years of age.
Subject is willing and able to provide written Informed Consent using a Patient Information and Consent form that has been reviewed and approved by a governing Institutional Review Board (IRB).
Subject has a history of habitual snoring (almost every night or every night for at least 30% of the night) as determined by the subject or a bed-partner.
Subject has been pre-screened and demonstrates no excess daytime sleepiness on an Epworth Questionnaire (an assessment of daytime sleepiness; high number = greater sleepiness) score of less than 11, no history of witnessed apneas or nocturnal gasping/choking episodes and a body mass index (BMI) ≤ 35.
Inclusion Criteria for treatment trials (Nights 2 and 3):
Subject meets Inclusion Criteria for the Baseline Trial (criteria a-d above)
The subject has snoring intensity that exceeds 40 dBA during ≥30% of the respiratory efforts during sleep time on the baseline study night.
Exclusion Criteria:
Subject has been diagnosed with COPD (Chronic Obstructive Pulmonary Disease), such as asthma, emphysema or chronic bronchitis.
Subject has a history of heart disease, heart attack or stroke.
Subject has uncontrolled or poorly controlled hypertension.
Subject has been diagnosed with Obstructive Sleep Apnea (OSA), defined as an apnea hypopnea index (AHI) ≥ 5/hr in the presence of excessive sleepiness (an Epworth score ≥ 11) or AHI ≥15/hr when there is no evidence of excessive daytime sleepiness (an Epworth score ≤ 10).
Subject is currently participating in another clinical study for which follow-up is ongoing.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Lauk
Organizational Affiliation
inSleep Tech
Official's Role
Study Director
Facility Information:
Facility Name
NeuroTrials Research, Inc.
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Johns Hopkins Bayview Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States
Facility Name
Doctors Community Hospital
City
Lanham
State/Province
Maryland
ZIP/Postal Code
20706
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
28356182
Citation
Guzman MA, Sgambati FP, Pho H, Arias RS, Hawks EM, Wolfe EM, Otvos T, Rosenberg R, Dakheel R, Schneider H, Kirkness JP, Smith PL, Schwartz AR. The Efficacy of Low-Level Continuous Positive Airway Pressure for the Treatment of Snoring. J Clin Sleep Med. 2017 May 15;13(5):703-711. doi: 10.5664/jcsm.6588.
Results Reference
derived
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Study of Nasal Airflow Pressure Optimization to Resolve Excessive Snoring
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