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).
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
26
Low level continuous positive airway pressure delivered during sleep.
NeuroTrials Research, Inc.
Atlanta, Georgia, United States
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States
Doctors Community Hospital
Lanham, Maryland, United States
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%.
Time frame: single night of sleep
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.
Time frame: two different single nights
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