- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT00005320
Regulation of Pharyngeal Muscle Contraction - SCOR in Cardiopulmonary Disorders of Sleep
Studie Overzicht
Toestand
Conditie
Gedetailleerde beschrijving
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).
Studietype
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Studie plan
Hoe is de studie opgezet?
Medewerkers en onderzoekers
Onderzoekers
- Susan Redline (Sub-project PI), Case Western Reserve University
Publicaties en nuttige links
Algemene publicaties
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Studie record data
Bestudeer belangrijke data
Studie start
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 4097
- P50HL042215-10 (Subsidie/contract van de Amerikaanse NIH)
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
Klinische onderzoeken op Slaapapneusyndromen
-
The Champ FoundationChildren's Hospital of Philadelphia; The Cleveland ClinicWervingPearson-syndroom | Single Large Scale Mitochondrial DNA Deletion Syndromes (SLSMDS)Verenigde Staten