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Trans Nasal Insuflation for the Treatment of Snoring (TNI)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2009 by Johns Hopkins University.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00832026
First received: January 27, 2009
Last updated: January 28, 2009
Last verified: January 2009
  Purpose

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.


Condition Intervention
Obstructive Sleep Apnea
Device: Trans Nasal Insuflation (TNI) [nasal canula]

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Trans Nasal Insuflation for the Treatment of Snoring and Obstructive Sleep Apnea

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Change in inspiratory airflow [ Time Frame: 2 nights ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in sleep apnea severity (AHI) [ Time Frame: 2 nights ] [ Designated as safety issue: No ]
  • Change in Ratio of apnea-to-hypopnea events [ Time Frame: 2-nights ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: July 2004
Groups/Cohorts Assigned Interventions
Sleep apnea
Patients with diagnosed obstructive sleep apnea
Device: Trans Nasal Insuflation (TNI) [nasal canula]

Trans Nasal Insuflation, 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.


  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

People with obstructive sleep apnea are eligbile to participate in this study.

Criteria

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 OSA;
  • Tracheostomy;
  • Allergy to lidocaine
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00832026

Locations
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21224
Sponsors and Collaborators
Johns Hopkins University
  More Information

Publications:
Responsible Party: Hartmut Schneider, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00832026     History of Changes
Other Study ID Numbers: NA_00019483
Study First Received: January 27, 2009
Last Updated: January 28, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins University:
sleep apnea
snoring
sleep apnea treatment
TNI
Trans nasal insuflation
Open CPAP

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Snoring
Dyssomnias
Nervous System Diseases
Respiration Disorders
Respiratory Sounds
Respiratory Tract Diseases
Signs and Symptoms
Signs and Symptoms, Respiratory
Sleep Disorders
Sleep Disorders, Intrinsic

ClinicalTrials.gov processed this record on November 20, 2014