Clinical trial NCT01949584: Study of Nasal Airflow Pressure Optimization to Resolve Excessive Snoring
Official title: Study of Nasal Airflow Pressure Optimization to Resolve Excessive Snoring
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Snoring
Lead sponsor: inSleep Technologies, LLC
Sponsor class: INDUSTRY
Collaborators: name: Johns Hopkins University
name: Doctors Community Hospital
name: NeuroTrials Research, Inc.
First posted: 2013-09-24
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Efficacy - The Cloud9™ device is expected to reduce the incidence of snoring.
timeFrame: single night of sleep
Secondary outcomes:
measure: Safety - Adverse events associated with CPAP (nasal or skin irritation, epistaxis and sleep disruption) will occur in few subjects.
timeFrame: two different single nights
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: NeuroTrials Research, Inc.
state: Georgia
city: Baltimore
country: United States
facility: Johns Hopkins Bayview Medical Center
state: Maryland
city: Lanham
country: United States
facility: Doctors Community Hospital
state: Maryland
Study officials:
affiliation: inSleep Tech
name: Michael Lauk
role: STUDY_DIRECTOR
References:
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.