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| Name | Class |
|---|---|
| Johns Hopkins University | OTHER |
| Doctors Community Hospital | UNKNOWN |
| NeuroTrials Research, Inc. | OTHER |
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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 Cloud9â„¢ 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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nasal continuous positive airway pressure less than or equal to 6 cm H2O | Device | Low level continuous positive airway pressure delivered during sleep. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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%. | single night of sleep |
| Measure | Description | Time Frame |
|---|---|---|
| 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 Cloud9â„¢ device (nasal or skin irritation, epistaxis and sleep disruption) will occur in fewer than 20% of the subjects in this study. | two different single nights |
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Inclusion Criteria:
Inclusion Criteria for treatment trials (Nights 2 and 3):
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Lauk | inSleep Tech | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NeuroTrials Research, Inc. | Atlanta | Georgia | 30342 | United States | ||
| Johns Hopkins Bayview Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28356182 | Derived | 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. |
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| ID | Term |
|---|---|
| D012913 | Snoring |
| ID | Term |
|---|---|
| D012135 | Respiratory Sounds |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Baltimore |
| Maryland |
| 21224 |
| United States |
| Doctors Community Hospital | Lanham | Maryland | 20706 | United States |