Trans Nasal Insufflation for the Treatment of Snoring

Completed

• Conditions: Obstructive Sleep Apnea
• Interventions: Device: Trans Nasal Insufflation (TNI) [nasal canula]

• Registration Number: NCT00832026
• Lead Sponsor: Johns Hopkins University

Brief Summary

This research is being done to examine if a nasal cannula can be used to keep the throat open during sleep, thereby treating sleep apnea.

People with sleep apnea and people who snore without sleep apnea may take part in this study. Sleep apnea is a disorder caused by pauses in breathing due to repetitive closure of the throat. The most common form of treatment for sleep apnea is continuous positive airway pressure (CPAP) therapy. While CPAP therapy remains the simplest and most effective treatment for snoring and sleep apnea, patients have to wear a nasal mask throughout the night. For this reason, patients often have difficulty sticking to therapy.

Participants enrolled in this study will spend 3-nights in a sleep laboratory. In all nights, the investigators will monitor your sleep and your breathing throughout the night. The investigators will apply several electrodes (sensors) to your scalp and face to monitor your sleep and breathing, and other sensors to your chest, abdomen, cheek, and a finger to monitor your breathing and oxygen level.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-07
• Primary Completion: 2006-03
• Study Completion: 2006-03
• Study First Submitted: 2009-01-27
• Study First Submitted QC: 2009-01-28
• Study First Posted: 2009-01-29
• Status Verified: 2018-09
• Last Update Submitted: 2023-05-10
• Last Update Posted: 2023-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

• Consenting adults over the age of 21
• Diagnosed obstructive sleep apnea

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Exclusion Criteria

• Unstable cardiovascular disease
• Uncontrolled hypertension (BP > 190/110)
• Severe intrinsic lung diseases (supplemental O2 > 2 L/min during the day)
• History of chronic renal insufficiency
• History of hepatic insufficiency
• Pregnancy
• Bleeding disorders or Coumadin use
• Sleep Disorders other than Obstructive Sleep Apnea (OSA)
• Tracheostomy
• Allergy to lidocaine

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Sleep apnea	Trans Nasal Insufflation (TNI) [nasal canula]	Patients with diagnosed obstructive sleep apnea

Primary Outcome Measures

Name	Time	Method
Change in inspiratory airflow	2 nights

Secondary Outcome Measures

Name	Time	Method
Change in sleep apnea severity (AHI)	2 nights
Change in Ratio of apnea-to-hypopnea events	2-nights

Trial Locations

Locations (1)

Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States