Trans Nasal Insufflation for the Treatment of Snoring

NCT ID: NCT00832026

Last Updated: 2023-05-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

11 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-07-31

Study Completion Date

2006-03-31

Brief Summary

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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

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Conditions

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Obstructive Sleep Apnea

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Sleep apnea

Patients with diagnosed obstructive sleep apnea

Trans Nasal Insufflation (TNI) [nasal canula]

Intervention Type DEVICE

Trans Nasal Insufflation, or TNI, uses air at flow rates delivered through a small nasal canula to reduce the severity and frequency of sleep apnea events.

By using TNI we hope to increase the amount of air that the patient can breathe during periods of obstructive sleep disordered breathing.

Interventions

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Trans Nasal Insufflation (TNI) [nasal canula]

Trans Nasal Insufflation, or TNI, uses air at flow rates delivered through a small nasal canula to reduce the severity and frequency of sleep apnea events.

By using TNI we hope to increase the amount of air that the patient can breathe during periods of obstructive sleep disordered breathing.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Johns Hopkins University

Baltimore, Maryland, United States

Site Status

Countries

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United States

References

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McGinley BM, Patil SP, Kirkness JP, Smith PL, Schwartz AR, Schneider H. A nasal cannula can be used to treat obstructive sleep apnea. Am J Respir Crit Care Med. 2007 Jul 15;176(2):194-200. doi: 10.1164/rccm.200609-1336OC. Epub 2007 Mar 15.

Reference Type RESULT
PMID: 17363769 (View on PubMed)

Other Identifiers

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NA_00019483

Identifier Type: -

Identifier Source: org_study_id

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