Lung DiseasesNCT00005511
SCOR in Neurobiology of Sleep--Intermediate Traits for Sleep Apnea
An observational study of Lung Diseases and Sleep Apnea Syndromes, run by University of Pennsylvania.
Trial summary
To determine intermediate traits for sleep apnea in a case-control study. Read more about this study
- Who is it for?
- Ages Up to 100 years
- Conditions the study is for
- Lung Diseases, Sleep Apnea Syndromes
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Sep 1998to Aug 2003
- 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 Up to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
No eligibility criteria
About this study
To determine intermediate traits for sleep apnea in a case-control study.
Read the detailed description
BACKGROUND:
Sleep apnea is a common condition that affects 4 percent of middle-aged males and 2 percent of middle-aged females. There is recent evidence that there is a genetic influence because first degree relatives of patients with this disorder have an increased risk of having obstructive sleep apnea. The basis for this increased familial risk is undefined. The investigators postulated that there were three specific intermediate traits, each of which reduced upper airway size, thereby increasing the risk of sleep apnea. These intermediate traits included: a) particular distribution of fat in the neck; b) craniofacial structure; and c) size of critical soft tissues in the airway (soft palate, tongue, lateral pharyngeal walls). All of these risk factors could be assessed quantitatively using advanced magnetic resonance imaging and novel volumetric image analysis techniques that had been developed..
The study was one project within a Specialized Center of Research in Neurobiology of Sleep and Sleep Apnea.
DESIGN NARRATIVE:
The case-control study identified the structural risk factors for sleep apnea. The study was complemented by studies in siblings of the patients and controls in order to identify those traits that demonstrated family aggregation not explained by shared environmental factors. The investigators believed that these structural risk factors would interact to increase the risk of sleep apnea. The elucidation of upper airway structural risk factors should provide the basis for developing new, more effective techniques for screening patients for sleep apnea and provide the basis for performing future DNA analyses aimed at identifying the genetic loci for these risk factors.
The specific aims were: 1) to quantify upper airway craniofacial structure, soft tissues and regional fat deposition using three dimensional magnetic resonance imaging in order to determine the intermediate traits associated with obstructive sleep apnea utilizing a case control design in normals and apneics; and 2) to determine the upper airway structural risk factors for sleep apnea that demonstrated family aggregation and were most likely to have a genetic component by comparing probands, siblings of probands, neighborhood controls and siblings of neighborhood controls. The resources included an extensive clinical sleep practice, sophisticated NM imaging techniques, novel volumetric computer graphics image analysis and expertise in molecular epidemiology, craniofacial structure, and the genetics of obesity.
- Conditions
- Lung Diseases, Sleep Apnea Syndromes
- Medical subject headings
- Lung Diseases, Sleep Apnea Syndromes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2000 (estimated)
- Study startSep 1998
- Primary completionAug 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Lung DiseasesStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Richard. Schwab, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005511
- Sponsor's protocol ID
- 5029
- Other IDs
- P50HL060287
- Status last verified
- Jan 2016
- First submitted
- 25 May 2000
- Last updated
- 20 Jan 2016
- Results posted
- No
Publications
Schellenberg JB, Maislin G, Schwab RJ. Physical findings and the risk for obstructive sleep apnea. The importance of oropharyngeal structures. Am J Respir Crit Care Med. 2000 Aug;162(2 Pt 1):740-8. doi: 10.1164/ajrccm.162.2.9908123.
PubMed 10934114Welch KC, Foster GD, Ritter CT, Wadden TA, Arens R, Maislin G, Schwab RJ. A novel volumetric magnetic resonance imaging paradigm to study upper airway anatomy. Sleep. 2002 Aug 1;25(5):532-42.
PubMed 12150320Schwab RJ. Imaging for the snoring and sleep apnea patient. Dent Clin North Am. 2001 Oct;45(4):759-96.
PubMed 11699240Schwab RJ, Pasirstein M, Pierson R, Mackley A, Hachadoorian R, Arens R, Maislin G, Pack AI. Identification of upper airway anatomic risk factors for obstructive sleep apnea with volumetric magnetic resonance imaging. Am J Respir Crit Care Med. 2003 Sep 1;168(5):522-30. doi: 10.1164/rccm.200208-866OC. Epub 2003 May 13.
PubMed 12746251
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SCOR in Neurobiology of Sleep--Intermediate Traits for Sleep Apnea
- ClinicalTrials.gov ID
- NCT00005511
- Acronym / sponsor ID
- 5029
- Conditions
- Lung Diseases, Sleep Apnea Syndromes
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Sep 1998
- Primary completion
- Aug 2003 (actual)
- First posted
- 26 May 2000 (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.
To determine intermediate traits for sleep apnea in a case-control study.
Detailed description
BACKGROUND:
Sleep apnea is a common condition that affects 4 percent of middle-aged males and 2 percent of middle-aged females. There is recent evidence that there is a genetic influence because first degree relatives of patients with this disorder have an increased risk of having obstructive sleep apnea. The basis for this increased familial risk is undefined. The investigators postulated that there were three specific intermediate traits, each of which reduced upper airway size, thereby increasing the risk of sleep apnea. These intermediate traits included: a) particular distribution of fat in the neck; b) craniofacial structure; and c) size of critical soft tissues in the airway (soft palate, tongue, lateral pharyngeal walls). All of these risk factors could be assessed quantitatively using advanced magnetic resonance imaging and novel volumetric image analysis techniques that had been developed..
The study was one project within a Specialized Center of Research in Neurobiology of Sleep and Sleep Apnea.
DESIGN NARRATIVE:
The case-control study identified the structural risk factors for sleep apnea. The study was complemented by studies in siblings of the patients and controls in order to identify those traits that demonstrated family aggregation not explained by shared environmental factors. The investigators believed that these structural risk factors would interact to increase the risk of sleep apnea. The elucidation of upper airway structural risk factors should provide the basis for developing new, more effective techniques for screening patients for sleep apnea and provide the basis for performing future DNA analyses aimed at identifying the genetic loci for these risk factors.
The specific aims were: 1) to quantify upper airway craniofacial structure, soft tissues and regional fat deposition using three dimensional magnetic resonance imaging in order to determine the intermediate traits associated with obstructive sleep apnea utilizing a case control design in normals and apneics; and 2) to determine the upper airway structural risk factors for sleep apnea that demonstrated family aggregation and were most likely to have a genetic component by comparing probands, siblings of probands, neighborhood controls and siblings of neighborhood controls. The resources included an extensive clinical sleep practice, sophisticated NM imaging techniques, novel volumetric computer graphics image analysis and expertise in molecular epidemiology, craniofacial structure, and the genetics of obesity.
Study design
Who may qualify
- Ages
- Up to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 20 Jan 2016.
- Background: PubMed 10934114Schellenberg JB, Maislin G, Schwab RJ. Physical findings and the risk for obstructive sleep apnea. The importance of oropharyngeal structures. Am J Respir Crit Care Med. 2000 Aug;162(2 Pt 1):740-8. doi: 10.1164/ajrccm.162.2.9908123.
- Background: PubMed 12150320Welch KC, Foster GD, Ritter CT, Wadden TA, Arens R, Maislin G, Schwab RJ. A novel volumetric magnetic resonance imaging paradigm to study upper airway anatomy. Sleep. 2002 Aug 1;25(5):532-42.
- Background: PubMed 11699240Schwab RJ. Imaging for the snoring and sleep apnea patient. Dent Clin North Am. 2001 Oct;45(4):759-96.
- Background: PubMed 12746251Schwab RJ, Pasirstein M, Pierson R, Mackley A, Hachadoorian R, Arens R, Maislin G, Pack AI. Identification of upper airway anatomic risk factors for obstructive sleep apnea with volumetric magnetic resonance imaging. Am J Respir Crit Care Med. 2003 Sep 1;168(5):522-30. doi: 10.1164/rccm.200208-866OC. Epub 2003 May 13.
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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.
Richard. Schwab
University of Pennsylvania
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Diseases and Sleep Apnea Syndromes, run by University of Pennsylvania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 20 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00005511, which also lists 4 linked publications.
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 20 Jan 2016.