Sleep-Disordered BreathingNCT00004569
Incorporating Flow Limitation Into the Diagnosis and Quantification of Sleep Disordered Breathing
A study testing Non-invasive technique to diagnose and quantitate sleep-disordered breathing in people with Sleep-Disordered Breathing, run by National Center for Research Resources (NCRR) at 1 site in United States.
Trial summary
The diagnosis and treatment of sleep disordered breathing have come to the forefront of clinical medicine following recognition of the high prevalence and associated morbidity of sleep apnea. The effects on quality of life as well as societal costs have been well documented. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep-Disordered Breathing
- What is being tested?
- Non-invasive technique to diagnose and quantitate sleep-disordered breathing
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Interventional
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with sleep disordered breathing
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
NYU Sleep Disorders Center
New York, New York, 10016
About this study
The diagnosis and treatment of sleep disordered breathing have come to the forefront of clinical medicine following recognition of the high prevalence and associated morbidity of sleep apnea. The effects on quality of life as well as societal costs have been well documented. The NYU Sleep Research Laboratory has spent the last several years working on the problem of improving the diagnosis of mild sleep disordered breathing which manifests as the upper airway resistance syndrome. Our approach has been to develop a non-invasive technique to detect increased upper airway resistance directly from analysis of the airflow signal. A characteristic intermittent change of the inspiratory flow contour, which is indicative of the occurrence of flow limitation, correlates well with increased airway resistance.
Currently all respiratory events are identified manually and totaled. This is time consuming and subject to variability. The objective of the present project is to improve upon the manual approach by implementing an artificially intelligent system for the identification and quantification of sleep disordered breathing based solely on non-invasive cardiopulmonary signals collected during a routine sleep study. The utility of other reported indices of sleep disordered breathing obtained during a sleep study will be evaluated.
Successful development of an automated system that can identify and classify upper airway resistance events will simplify, standardize and improve the diagnosis of sleep disordered breathing, and greatly facilitate research and clinical work in this area. Using a physiological based determination of disease should allow better assessment of treatment responses in mild disease.
- Conditions
- Sleep-Disordered Breathing
- Being tested
- Non-invasive technique to diagnose and quantitate sleep-disordered breathing
- Medical subject headings
- Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-invasive technique to diagnose and quantitate sleep-disordered breathingProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2000 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep-Disordered BreathingStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
Sponsor and investigators
- Lead sponsor
- National Center for Research Resources (NCRR)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00004569
- Sponsor's protocol ID
- NCRR-M01RR00096-0938
- Other IDs
- M01RR000096
- Status last verified
- Jan 2004
- First submitted
- 12 Feb 2000
- Last updated
- 24 Jun 2005
- Results posted
- No