Study of Nasal Airflow Pressure Optimization to Resolve Excessive Snoring
| Status: | Completed |
|---|---|
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/16/2015 |
| Start Date: | August 2013 |
| End Date: | December 2013 |
| Contact: | Michelle Guzman |
| Email: | mguzman4@jhmi.edu |
| Phone: | (410) 550-6336 |
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).
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).
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.
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.
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.
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