Study of Nasal Airflow Pressure Optimization to Resolve Excessive Snoring

NCT ID: NCT01949584

Last Updated: 2015-03-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-31
• Study Completion Date: 2014-12-31

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.

Conditions

Snoring

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

nasal continuous positive airway pressure less than or equal to 6 cm H2O

Low level continuous positive airway pressure delivered during sleep.

Intervention Type: DEVICE

Other Intervention Names

Cloud9™ nasal CPAP device and nasal interface

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.

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Johns Hopkins University

OTHER

Sponsor Role: collaborator

Doctors Community Hospital

UNKNOWN

Sponsor Role: collaborator

NeuroTrials Research, Inc.

OTHER

Sponsor Role: collaborator

inSleep Technologies, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Lauk

Role: STUDY_DIRECTOR

inSleep Tech

Locations

NeuroTrials Research, Inc.

Atlanta, Georgia, United States

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, United States

Doctors Community Hospital

Lanham, Maryland, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 28356182 (View on PubMed)

Other Identifiers

IS103-PRO-00002

Identifier Type: -

Identifier Source: org_study_id