Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

SCOR in Neurobiology of Sleep--Intermediate Traits for Sleep Apnea

This study has been completed.
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00005511
First received: May 25, 2000
Last updated: January 19, 2016
Last verified: January 2016

May 25, 2000
January 19, 2016
September 1998
August 2003   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00005511 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
SCOR in Neurobiology of Sleep--Intermediate Traits for Sleep Apnea
Not Provided
To determine intermediate traits for sleep apnea in a case-control study.

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.

Observational
Not Provided
Not Provided
Not Provided
Not Provided
Not Provided
  • Lung Diseases
  • Sleep Apnea Syndromes
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
Not Provided
Not Provided
August 2003   (final data collection date for primary outcome measure)
No eligibility criteria
Both
up to 100 Years   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00005511
5029, P50HL060287
Not Provided
Not Provided
Not Provided
University of Pennsylvania
University of Pennsylvania
National Heart, Lung, and Blood Institute (NHLBI)
Investigator: Richard. Schwab University of Pennsylvania
University of Pennsylvania
January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP