Study of Nasal Airflow Pressure Optimization to Resolve Excessive Snoring

Snoring Clinical Trial

— SNORE  

Official title:

Study of Nasal Airflow Pressure Optimization to Resolve Excessive Snoring

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01949584
• Other study ID #: IS103-PRO-00002
• Status: Completed
• Phase: N/A
• First received: September 20, 2013
• Last updated: March 23, 2015
• Start date: August 2013
• Est. completion date: December 2014

Study information

• Verified date: March 2015
• Source: inSleep Technologies, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: December 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Snoring

Intervention

Device:
• nasal continuous positive airway pressure less than or equal to 6 cm H2O
Low level continuous positive airway pressure delivered during sleep.

Locations

Country	Name	City	State
United States	NeuroTrials Research, Inc.	Atlanta	Georgia
United States	Johns Hopkins Bayview Medical Center	Baltimore	Maryland
United States	Doctors Community Hospital	Lanham	Maryland

Sponsors (4)

Lead Sponsor	Collaborator
inSleep Technologies, LLC	Doctors Community Hospital, Johns Hopkins University, NeuroTrials Research, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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.	two different single nights	Yes