Obstructive Sleep ApneaTNINCT00832026
Trans Nasal Insufflation for the Treatment of Snoring
An observational study of Obstructive Sleep Apnea, run by Johns Hopkins University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Trans Nasal Insufflation (TNI) [nasal canula]
- Type of treatment
- Medical device
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2004to Mar 2006
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: People with obstructive sleep apnea are eligbile to participate in this study.
Who may be able to join
- Consenting adults over the age of 21
- Diagnosed obstructive sleep apnea
Who cannot join
- 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
Show all 10Show fewer
- Bleeding disorders or Coumadin use
- Sleep Disorders other than Obstructive Sleep Apnea (OSA)
- Tracheostomy
- Allergy to lidocaine
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Trans Nasal Insufflation for the Treatment of Snoring and Obstructive Sleep Apnea
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.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Trans Nasal Insufflation (TNI) [nasal canula]
- Keywords
- sleep apnea, snoring, sleep apnea treatment, TNI, Trans nasal insufflation, Open CPAP
- Medical subject headings
- Sleep Apnea, Obstructive, Sleep Apnea Syndromes, Snoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trans Nasal Insufflation (TNI) [nasal canula]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.
| Study group | Role | What they receive |
|---|---|---|
| Sleep apnea | Patients with diagnosed obstructive sleep apnea Receives: Device: Trans Nasal Insufflation (TNI) [nasal canula] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in inspiratory airflow
Measured: 2 nights
Secondary outcomes (2)
Change in sleep apnea severity (AHI)
Measured: 2 nights
Change in Ratio of apnea-to-hypopnea events
Measured: 2-nights
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2009 (estimated)
- Study startJul 2004
- Primary completionMar 2006
- Study completionMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00832026
- Sponsor's protocol ID
- NA_00019483
- Acronym
- TNI
- Status last verified
- Sep 2018
- First submitted
- 27 Jan 2009
- Last updated
- 12 May 2023
- Results posted
- No
- Data monitoring committee
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trans Nasal Insufflation for the Treatment of Snoring and Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT00832026
- Acronym / sponsor ID
- TNI / NA_00019483
- Conditions
- Obstructive Sleep Apnea
- Keywords
- sleep apnea, snoring, sleep apnea treatment, TNI, Trans nasal insufflation, Open CPAP
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- Jul 2004
- Primary completion
- Mar 2006 (actual)
- Study completion
- Mar 2006 (actual)
- First posted
- 29 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sleep apnea | – | Device: Trans Nasal Insufflation (TNI) [nasal canula]Patients with diagnosed obstructive sleep apnea |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- People with obstructive sleep apnea are eligbile to participate in this study.
Key inclusion criteria (2 listed)
- Consenting adults over the age of 21
- Diagnosed obstructive sleep apnea
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Sleep apnea |
Primary outcome
Change in inspiratory airflow
Time frame: 2 nights
2 secondary outcomes
Change in sleep apnea severity (AHI)
Time frame: 2 nights
Change in Ratio of apnea-to-hypopnea events
Time frame: 2-nights
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2023.
- Results publication: PubMed 17363769McGinley 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in inspiratory airflow (time frame: 2 nights). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00832026, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2023.