Study of Nasal Airflow Pressure Optimization to Resolve Excessive Snoring

NCT01949584 | Completed DMC

• 1 other identifier: IS103-PRO-00002
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 3

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).

Conditions

Snoring

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Safety - Adverse events associated with CPAP (nasal or skin irritation, epistaxis and sleep disruption) will occur in few subjects.

  two different single nights

Interventions

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

Low level continuous positive airway pressure delivered during sleep.

Also known as: Cloud9™ nasal CPAP device and nasal interface

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.
• 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.

Sponsors & Collaborators

• inSleep Technologies, LLC: lead
• Johns Hopkins University: collaborator
• Doctors Community Hospital: collaborator
• NeuroTrials Research, Inc.: collaborator

Study Sites (3)

NeuroTrials Research, Inc.

Atlanta, Georgia, 30342, United States

Location

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

Location

Doctors Community Hospital

Lanham, Maryland, 20706, United States

Location

Related Publications (1)

• 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.

  PMID: 28356182 DERIVED

MeSH Terms

Conditions

Snoring

Condition Hierarchy (Ancestors)

Respiratory Sounds; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Michael Lauk

  inSleep Tech

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2013
• First Posted: September 24, 2013
• Study Start: August 1, 2013
• Primary Completion: July 1, 2014
• Study Completion: December 1, 2014
• Last Updated: March 24, 2015

Record last verified: 2015-03

Locations

US (3)