Ignite Creation Date:
2024-05-06 @ 12:00 AM
Last Modification Date:
2024-10-26 @ 10:42 AM
Study NCT ID:
NCT01461486
Status:
COMPLETED
Last Update Posted:
2019-11-13
First Post:
2011-10-25
Brief Title:
Continuous Positive Airway Pressure and Oral Appliances Treatments in Mild Obstructive Sleep Apnea
Sponsor:
Associação Fundo de Incentivo à Pesquisa
Organization:
Associação Fundo de Incentivo à Pesquisa
Study Overview
Official Title:
Effectiveness of Continuous Positive Airway Pressure and Oral Appliances in Mild Obstructive Sleep Apnea a Randomized Parallel Single Blind and Controlled Study
Status:
COMPLETED
Status Verified Date:
2019-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OSAS
Brief Summary:
Treatment response of mild obstructive sleep apnea OSA to continuous positive airway pressure CPAP therapy and oral appliance OA is still controversial The aim of this study is to evaluate the effect of CPAP and OA treatment on objective and subjective sleepiness cognitive deficits mood changes quality of life inflammatory profile and metabolic cardiovascular and hormonal alterations in mild OSA subjects Subjects with mild OSA apnea -hypopnea index of 5 or more events per hour of sleep and less than 15 both genders body mass index lower than 35Kgm2 and age between 18 to 65 years will be included They also must have a minimum mandibular protrusion of 7mm Subjects will be randomly distributed in three groups group 1 with CPAP group 2 with OA and group 3 will be the control At baseline evaluation six months one year and three years all subjects will be submitted to sleep questionnaires physical examination ear-nose and throat evaluation baseline polysomnography and with CPAP for groups 1 Epworth Sleepiness Scale Karolinska Sleepiness Scale Stanford Sleepiness Scale Maintenance of Wakefulness Test Chalder Fatigue Scale Neurocognitive testing Beck Inventories of anxiety and depression Functional Outcomes of Sleep Questionnaire FOSQ WHOQOL-BREF quality of life questionnaire Short Form-36 quality of life questionnaire questionnaire for sexual dysfunction blood analysis for inflammatory metabolic and hormonal evaluation assessment of heart rate variability 24 hour blood pressure monitoring and endothelial dysfunction Sleep hygiene care was offer to three groups Analysis mean and standard deviation will be used for descriptive statistical and a general linear model will be applied for analysis within groups on different time
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None