Trial Outcomes & Findings for Continuous Positive Airway Pressure (CPAP), Oral Appliance and Physical Exercise in the Obstructive Sleep Apnea (NCT NCT01289392)

Results Overview

Polysomnographic date of sleep stages percentages, sleep efficiency, arousals, apnea-hypopnea index, oxyhemoglobin saturation

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

25 participants

Primary outcome timeframe

6 months after the basal evaluation

Results posted on

2013-05-03

Participant Flow

sleep disorder clinic

Participant milestones

Participant milestones
Measure	Continuous Positive Airway Pressure (CPAP) CPAP is the gold standard treatment Continuous Positive Airway Pressure (CPAP) : Previously determinated airway pressure: used for two months unassociated with physical exercise and used for four months associated with physical exercise	Oral Appliance Alternative treatment for obstructive sleep apnea patients Oral Appliance (OA) : Anterior mandibular repositioner: used for two months unassociated with physical exercise and used for four months associated with physical exercise	Physical Exercise Aerobic and resistance physical exercises Physical Exercise : aerobic and resistance Physical exercise, three times a week, for four months
Overall Study STARTED	9	9	7
Overall Study COMPLETED	9	9	7
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Continuous Positive Airway Pressure (CPAP), Oral Appliance and Physical Exercise in the Obstructive Sleep Apnea

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Continuous Positive Airway Pressure (CPAP) n=9 Participants CPAP is the gold standard treatment Continuous Positive Airway Pressure (CPAP) : Previously determinated airway pressure: used for two months unassociated with physical exercise and used for four months associated with physical exercise	Oral Appliance n=9 Participants Alternative treatment for obstructive sleep apnea patients Oral Appliance (OA) : Anterior mandibular repositioner: used for two months unassociated with physical exercise and used for four months associated with physical exercise	Physical Exercise n=7 Participants Aerobic and resistance physical exercises Physical Exercise : aerobic and resistance Physical exercise, three times a week, for four months	Total n=25 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=93 Participants	9 Participants n=4 Participants	7 Participants n=27 Participants	25 Participants n=483 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Age Continuous	38.62 years STANDARD_DEVIATION 8.15 • n=93 Participants	42.33 years STANDARD_DEVIATION 6.20 • n=4 Participants	42.28 years STANDARD_DEVIATION 8.28 • n=27 Participants	41.10 years STANDARD_DEVIATION 7.27 • n=483 Participants
Sex: Female, Male Female	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Sex: Female, Male Male	9 Participants n=93 Participants	9 Participants n=4 Participants	7 Participants n=27 Participants	25 Participants n=483 Participants
Region of Enrollment Brazil	9 participants n=93 Participants	9 participants n=4 Participants	7 participants n=27 Participants	25 participants n=483 Participants

PRIMARY outcome

Timeframe: 6 months after the basal evaluation

Polysomnographic date of sleep stages percentages, sleep efficiency, arousals, apnea-hypopnea index, oxyhemoglobin saturation

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 6 months

Number of events per hour of sleep

Outcome measures

Outcome measures
Measure	Continuous Positive Airway Pressure (CPAP) n=9 Participants CPAP is the gold standard treatment Continuous Positive Airway Pressure (CPAP) : Previously determinated airway pressure: used for two months unassociated with physical exercise and used for four months associated with physical exercise	Oral Appliance n=9 Participants Alternative treatment for obstructive sleep apnea patients Oral Appliance (OA) : Anterior mandibular repositioner: used for two months unassociated with physical exercise and used for four months associated with physical exercise	Physical Exercise n=7 Participants Aerobic and resistance physical exercises Physical Exercise : aerobic and resistance Physical exercise, three times a week, for four months
Sleep Apnea	25.06 number of events Standard Deviation 10.54	30.76 number of events Standard Deviation 19.00	22.81 number of events Standard Deviation 12.77

SECONDARY outcome

Timeframe: 6 months after the basal evaluation

Blood samples to test: tumor necrosis factor-alpha (TNF-alpha), C-reactive protein (CRP), Interleukin-6 and Interleukin-8

Outcome measures

Outcome data not reported

Adverse Events

Continuous Positive Airway Pressure (CPAP)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Oral Appliance

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Physical Exercise

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Teresa Cristina Barros Schutz

Associação Fundo de Incentivo à Pesquisa

Phone: 55-21-99868033

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place