NCT01949584

Study of Nasal Airflow Pressure Optimization to Resolve Excessive Snoring

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: inSleep Technologies, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DEVICE	nasal continuous positive airway pressure less than or equal to 6 cm H2O	Low level continuous positive airway pressure delivered during sleep.

Timeline

• Start date: 2013-08-01
• Primary completion: 2014-07-01
• Completion: 2014-12-01
• First posted: 2013-09-24
• Last updated: 2015-03-24

Locations

3 sites across 1 country: United States