Ignite Creation Date:
2024-05-05 @ 11:27 PM
Last Modification Date:
2024-10-26 @ 10:34 AM
Study NCT ID:
NCT01336556
Status:
UNKNOWN
Last Update Posted:
2011-10-26
First Post:
2011-04-14
Brief Title:
Titration of Continuous Positive Airway Pressure Could Predict Success of Oral Appliance to Treat Sleep Apnea
Sponsor:
Associacao Fundo de Incentivo a Psicofarmcologia
Organization:
Associacao Fundo de Incentivo a Psicofarmcologia
Study Overview
Official Title:
Optimal Titration of Continuous Positive Airway Pressure Could Predict Success of Oral Appliance to Treat Obstructive Sleep Apnea Syndrome
Status:
UNKNOWN
Status Verified Date:
2011-10
Last Known Status:
RECRUITING
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:
None
Brief Summary:
Background The oral appliances have been increasingly used in the treatment of primary snoring and in patients with mild obstructive sleep apnea syndrome besides being treatment options in adults with moderate to severe sleep apnea who did not accept or adapt to continuous positive airway pressure CPAP It is not well established yet in the literature which patients with mild to moderate OSA will present a good response to treatment with oral appliances
Objective To determine a value of CPAP pressure that correlates with a favorable response to the use of oral appliance in patients with mild to moderate sleep apnea
Patients and Methods Two groups of 30 male patients 25-65 years body mass index 35 kgm2 will be selected the first group with an apnea-hypopnea index AHI between 5 and 15 events per hour of sleep and the second one with an AHI between 15 and 30 events per hour of sleep Each patient will undergo three polysomnographic recordings baseline CPAP titration after two months of treatment with oral appliance Subjective sleep disorders questionnaire the Epworth Sleepiness Scale and sleep diaries and objective polysomnography parameters of sleep will be evaluated besides the quality of life SF-36 mood POMS and anthropometric measurements neck circumference and craniofacial characteristic Good response to treatment with the AIO will be considered as a 50 reduction in the baseline AHI index or AHI after treatment less than 5 events per hour of sleep
Objective To determine a value of CPAP pressure that correlates with a favorable response to the use of oral appliance in patients with mild to moderate sleep apnea
Patients and Methods Two groups of 30 male patients 25-65 years body mass index 35 kgm2 will be selected the first group with an apnea-hypopnea index AHI between 5 and 15 events per hour of sleep and the second one with an AHI between 15 and 30 events per hour of sleep Each patient will undergo three polysomnographic recordings baseline CPAP titration after two months of treatment with oral appliance Subjective sleep disorders questionnaire the Epworth Sleepiness Scale and sleep diaries and objective polysomnography parameters of sleep will be evaluated besides the quality of life SF-36 mood POMS and anthropometric measurements neck circumference and craniofacial characteristic Good response to treatment with the AIO will be considered as a 50 reduction in the baseline AHI index or AHI after treatment less than 5 events per hour of sleep
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