Trial record 2 of 15 for:    Open Studies | "Snoring"

Study of Nasal Airflow Pressure Optimization to Resolve Excessive Snoring (SNORE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by inSleep Technologies, LLC
Sponsor:
Collaborators:
Johns Hopkins University
Doctors Community Hospital
NeuroTrials Research, Inc.
Information provided by (Responsible Party):
inSleep Technologies, LLC
ClinicalTrials.gov Identifier:
NCT01949584
First received: September 20, 2013
Last updated: September 30, 2013
Last verified: September 2013
  Purpose

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).


Condition Intervention
Habitual, Simple Snoring
Device: nasal continuous positive airway pressure less than or equal to 6 cm H2O

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Study of Nasal Airflow Pressure Optimization to Resolve Excessive Snoring

Resource links provided by NLM:


Further study details as provided by inSleep Technologies, LLC:

Primary Outcome Measures:
  • Efficacy - The Cloud9™ device is expected to reduce the incidence of snoring. [ Time Frame: single night of sleep ] [ Designated as safety issue: No ]
    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. [ Time Frame: two different single nights ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 30
Study Start Date: August 2013
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: nasal continuous positive airway pressure less than or equal to 6 cm H2O
    Low level continuous positive airway pressure delivered during sleep.
    Other Name: Cloud9™ nasal CPAP device and nasal interface
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01949584

Contacts
Contact: Michelle Guzman (410) 550-6336 mguzman4@jhmi.edu

Locations
United States, Georgia
NeuroTrials Research, Inc. Recruiting
Atlanta, Georgia, United States, 30342
Contact: Ronna Harris    404-851-9934    rharris@neurotrials.com   
Principal Investigator: Russell P. Rosenberg, PhD         
United States, Maryland
Johns Hopkins Bayview Medical Center Recruiting
Baltimore, Maryland, United States, 21224
Contact: Michelle Guzman    410-550-6336    mguzman4@jhmi.edu   
Principal Investigator: Alan Schwartz, MD         
Doctors Community Hospital Recruiting
Lanham, Maryland, United States, 20706
Contact: Barbara Draper    240-965-3619    bdraper@sleepservices.net   
Contact: Barbara Grimm    (240) 965-8452    bgrimm@dchweb.org   
Principal Investigator: Riad Dakheel, MD         
Sponsors and Collaborators
inSleep Technologies, LLC
Johns Hopkins University
Doctors Community Hospital
NeuroTrials Research, Inc.
  More Information

No publications provided

Responsible Party: inSleep Technologies, LLC
ClinicalTrials.gov Identifier: NCT01949584     History of Changes
Other Study ID Numbers: IS103-PRO-00002
Study First Received: September 20, 2013
Last Updated: September 30, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Snoring
Respiratory Sounds
Signs and Symptoms, Respiratory
Signs and Symptoms

ClinicalTrials.gov processed this record on September 22, 2014