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CompletedNCT00832026TNIUpdated May 12, 2023

Trans Nasal Insufflation for the Treatment of Snoring

An observational study in Obstructive Sleep Apnea, sponsored by Johns Hopkins University. Completed at 1 site in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2023-05-12.

Sponsored by Johns Hopkins University · Observational

Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
11
Ages
21 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Obstructive Sleep Apnea

Keywords

  • sleep apnea
  • snoring
  • sleep apnea treatment
  • TNI
  • Trans nasal insufflation
  • Open CPAP
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In context

Sleep Apnea, Obstructive

2,240 studies on the registry are indexed under Sleep Apnea, Obstructive; 475 are open to participants now.

This study's enrollment of 11 is below the median of 105 across 666 observational studies indexed under Sleep Apnea, Obstructive.

Browse Sleep Apnea, Obstructive studies →

Lead sponsor

Johns Hopkins University is the lead sponsor of 1,815 studies on the registry; 315 are open to participants now.

Of its 208 completed or terminated interventional studies of FDA-regulated products, 144 (69%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
21 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
11 participants (actual)

Groups and cohorts

  • Sleep apnea

    Patients with diagnosed obstructive sleep apnea

    Device: Trans Nasal Insufflation (TNI) [nasal canula]

Interventions

  • DeviceTrans 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.

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What researchers measure

Primary outcomes

  1. Change in inspiratory airflow

    Time frame: 2 nights

Secondary outcomes

  1. Change in sleep apnea severity (AHI)

    Time frame: 2 nights

  2. Change in Ratio of apnea-to-hypopnea events

    Time frame: 2-nights

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Study locations

1 site
  • Johns Hopkins University
    Baltimore, Maryland 21224, United States
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References and documents

Publications

  • 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. PubMed 17363769 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 12, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00832026
Responsible party
Sponsor
First posted
Jan 29, 2009
Start date
Jul 2004
Primary completion
Mar 2006
Completion
Mar 2006
Last update
May 12, 2023

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.

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Discussion

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