We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00005320
First Posted: May 26, 2000
Last Update Posted: September 28, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
  Purpose
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.

Condition
Lung Diseases Sleep Apnea Syndromes

Study Type: Observational

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date: September 1988
Study Completion Date: August 1998
Detailed Description:

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.

The study completion date listed in this record was obtained from the "Completed Date" entered in the Query View Report System (QVR).

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   up to 100 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria
No eligibility criteria
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00005320


Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
OverallOfficial: Susan Redline (Sub-project PI) Case Western Reserve University
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00005320     History of Changes
Other Study ID Numbers: 4097
P50HL042215-10 ( U.S. NIH Grant/Contract )
First Submitted: May 25, 2000
First Posted: May 26, 2000
Last Update Posted: September 28, 2016
Last Verified: March 2005

Additional relevant MeSH terms:
Lung Diseases
Sleep Apnea Syndromes
Respiratory Tract Diseases
Apnea
Respiration Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases