Study of Nasal Airflow Pressure Optimization to Resolve Excessive Snoring
Completed · Not applicable
Conditions studied: Snoring
In brief
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).
Key facts
- Study ID
- NCT01949584
- Run by
- inSleep Technologies, LLC
- People needed
- 26
- Starts
- 2013-08-01
- Expected to finish
- 2014-12-01
- Last updated by the study team
- 2015-03-24
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- NeuroTrials Research, Inc. — Atlanta, Georgia, United States
- Johns Hopkins Bayview Medical Center — Baltimore, Maryland, United States
- Doctors Community Hospital — Lanham, Maryland, United States
Full record on ClinicalTrials.gov
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