Regulation of Pharyngeal Muscle Contraction - SCOR in Cardiopulmonary Disorders of Sleep

This study has been completed.
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00005320
First received: May 25, 2000
Last updated: June 23, 2005
Last verified: March 2005

May 25, 2000
June 23, 2005
September 1988
Not Provided
Not Provided
Not Provided
Complete list of historical versions of study NCT00005320 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Regulation of Pharyngeal Muscle Contraction - SCOR in Cardiopulmonary Disorders of Sleep
Not Provided

To determine the degree to which neuro-psychological performance and general health status and function may be impaired in subjects with mild and moderate degrees of sleep-related respiratory disturbances (SRRD), as compared to subjects with minimal apneic activity. Also, to assess the degree to which improvement may occur following specific treatment.

BACKGROUND:

The study was a subproject in a Specialized Center of Research in the Cardiopulmonary Disorders of Sleep. Frequent sleep-related respiratory disturbances (SRRD) have been recognized to occur in as many as 70 percent of elderly and 15 percent of middle-aged subjects. Although it is widely agreed that subjects with obvious daytime sleepiness that occurs in association with severe obstructive sleep apnea (Respiratory disturbance indices (RDI) >30) benefit from treatment of their sleep disorders; there is no consensus (and a paucity of data) regarding treatment benefits in subjects with a less profound disorder. Rational utilization of health care resources for diagnosis and treatment of sleep apnea requires assessment of whether adverse health effects occur as a consequence of mild or moderate levels of SRRD, and whether any such health effects may be reversible with treatment.

DESIGN NARRATIVE:

The neuropsychological performance, sleepiness and general functional status were evaluated in 330 subjects, including subjects with little apneic activity (RDI<5), mild activity (RDI 5-14), and moderate activity (RDI 15-25). Of these subjects, 75 percent were selected from a clinic-based sample, and 25 percent were recruited from an ongoing population-based study. 150 subjects with mild and moderate activity were randomized to receive 'conservative' medical therapy (CMT) or CMT plus nasal continuous positive air pressure (CPAP) therapy. Simple statistics, as well as multivariate techniques, were used to determine the relationship between SRRD (and associated hypoxemia, sleep fragmentation, and physiological sleepiness) to: a) intellectual abilities, attention and vigilance, psychomotor performance, learning and memory, and executive functions, and b) to general health status and function. Potential benefits of treatment specific for sleep apnea in subjects with mild and moderate SRRD were also determined after two months of CPAP therapy.

Observational
Observational Model: Natural History
Time Perspective: Longitudinal
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
August 1998
Not Provided

No eligibility criteria

Male
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00005320
4097
Not Provided
Not Provided
National Heart, Lung, and Blood Institute (NHLBI)
Not Provided
Investigator: Susan Redline (Sub-project PI) Case Western Reserve University
National Heart, Lung, and Blood Institute (NHLBI)
March 2005

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