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

Primary Purpose

Lung Diseases, Sleep Apnea Syndromes

Status
Completed
Phase
Locations
Study Type
Observational
Intervention
Sponsored by
National Heart, Lung, and Blood Institute (NHLBI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Lung Diseases

Eligibility Criteria

undefined - 100 Years (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

No eligibility criteria

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    May 25, 2000
    Last Updated
    September 27, 2016
    Sponsor
    National Heart, Lung, and Blood Institute (NHLBI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00005320
    Brief Title
    Regulation of Pharyngeal Muscle Contraction - SCOR in Cardiopulmonary Disorders of Sleep
    Study Type
    Observational

    2. Study Status

    Record Verification Date
    March 2005
    Overall Recruitment Status
    Completed
    Study Start Date
    September 1988 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    August 1998 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    National Heart, Lung, and Blood Institute (NHLBI)

    4. Oversight

    5. Study Description

    Brief Summary
    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.
    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Lung Diseases, Sleep Apnea Syndromes

    7. Study Design

    10. Eligibility

    Sex
    Male
    Maximum Age & Unit of Time
    100 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    No eligibility criteria
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Susan Redline (Sub-project PI)
    Organizational Affiliation
    Case Western Reserve University

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    11401885
    Citation
    Adams N, Strauss M, Schluchter M, Redline S. Relation of measures of sleep-disordered breathing to neuropsychological functioning. Am J Respir Crit Care Med. 2001 Jun;163(7):1626-31. doi: 10.1164/ajrccm.163.7.2004014.
    Results Reference
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    PubMed Identifier
    9554214
    Citation
    Redline S, Strohl KP. Recognition and consequences of obstructive sleep apnea hypopnea syndrome. Clin Chest Med. 1998 Mar;19(1):1-19. doi: 10.1016/s0272-5231(05)70428-7.
    Results Reference
    background
    PubMed Identifier
    9517603
    Citation
    Redline S, Adams N, Strauss ME, Roebuck T, Winters M, Rosenberg C. Improvement of mild sleep-disordered breathing with CPAP compared with conservative therapy. Am J Respir Crit Care Med. 1998 Mar;157(3 Pt 1):858-65. doi: 10.1164/ajrccm.157.3.9709042.
    Results Reference
    background
    PubMed Identifier
    9143077
    Citation
    Redline S, Strauss ME, Adams N, Winters M, Roebuck T, Spry K, Rosenberg C, Adams K. Neuropsychological function in mild sleep-disordered breathing. Sleep. 1997 Feb;20(2):160-7. doi: 10.1093/sleep/20.2.160.
    Results Reference
    background
    PubMed Identifier
    8899938
    Citation
    Briones B, Adams N, Strauss M, Rosenberg C, Whalen C, Carskadon M, Roebuck T, Winters M, Redline S. Relationship between sleepiness and general health status. Sleep. 1996 Sep;19(7):583-8. doi: 10.1093/sleep/19.7.583.
    Results Reference
    background
    PubMed Identifier
    8756795
    Citation
    Strohl KP, Redline S. Recognition of obstructive sleep apnea. Am J Respir Crit Care Med. 1996 Aug;154(2 Pt 1):279-89. doi: 10.1164/ajrccm.154.2.8756795. No abstract available.
    Results Reference
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    Regulation of Pharyngeal Muscle Contraction - SCOR in Cardiopulmonary Disorders of Sleep

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