Ignite Creation Date:
2024-05-05 @ 11:14 PM
Last Modification Date:
2024-10-26 @ 10:31 AM
Study NCT ID:
NCT01289392
Status:
COMPLETED
Last Update Posted:
2013-05-03
First Post:
2011-01-31
Brief Title:
Continuous Positive Airway Pressure CPAP Oral Appliance and Physical Exercise in the Obstructive Sleep Apnea
Sponsor:
Associação Fundo de Incentivo à Pesquisa
Organization:
Associação Fundo de Incentivo à Pesquisa
Study Overview
Official Title:
Effects of the Treatment With Continuous Positive Airway Pressure CPAP and Oral Appliance Associated or Not Associated With Physical Exercise in the Obstructive Sleep Apnea
Status:
COMPLETED
Status Verified Date:
2013-03
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:
None
Brief Summary:
Introduction It is unclear whether exercise training with or without Continuous Positive Airway Pressure CPAP and Oral Appliance OA is more effective in reducing symptoms of Obstructive Sleep Apnea OSA than treatment solely with CPAP or OA
Objective In patients with moderate OSA the investigators will evaluate the effect on the subjective and objective measures of sleep quality of life and mood of different forms of treatment exercise training of 4 months exercise training of 4 months associated with CPAP and OA treatment with CPAP and treatment with OA
Material and Methods Sixty male patients 25-65 years sedentary lifestyle Body Mass Index BMI 35kgm2 Apnea-Hypopnea Index AHI between 15-30h Epworth sleepiness scale 9 will be divided into three groups CPAPexercise group CE n20 OAexercise group AE n20 and Exercise training group E n20 The patients in groups CE and AE will complete two months of treatment with CPAP or OA to examine the separate effects of these devices As the patients of the E group did not use the CPAP but will undergo four months of exercise training After this initial step patients in CE and AE groups will undergo four months of exercise training associated with CPAP or OA The investigators will evaluate the subjective sleep parameters sleep disorders questionnaire the Epworth Sleepiness Scale sleep diaries and objective polysomnography Short Form Health Survey SF-36 Questionnaire Profile of Mood States POMS and anthropometric measurements neck circumference and body composition the incremental exercise test ergospirometry and the one Repetition Maximum test 1RM
Objective In patients with moderate OSA the investigators will evaluate the effect on the subjective and objective measures of sleep quality of life and mood of different forms of treatment exercise training of 4 months exercise training of 4 months associated with CPAP and OA treatment with CPAP and treatment with OA
Material and Methods Sixty male patients 25-65 years sedentary lifestyle Body Mass Index BMI 35kgm2 Apnea-Hypopnea Index AHI between 15-30h Epworth sleepiness scale 9 will be divided into three groups CPAPexercise group CE n20 OAexercise group AE n20 and Exercise training group E n20 The patients in groups CE and AE will complete two months of treatment with CPAP or OA to examine the separate effects of these devices As the patients of the E group did not use the CPAP but will undergo four months of exercise training After this initial step patients in CE and AE groups will undergo four months of exercise training associated with CPAP or OA The investigators will evaluate the subjective sleep parameters sleep disorders questionnaire the Epworth Sleepiness Scale sleep diaries and objective polysomnography Short Form Health Survey SF-36 Questionnaire Profile of Mood States POMS and anthropometric measurements neck circumference and body composition the incremental exercise test ergospirometry and the one Repetition Maximum test 1RM
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