Erectile Dysfunction, Metabolic Syndrome, Obstructive Sleep Apnea
Conditions
Brief summary
The problems like metabolic syndrome and sexual impotence in males with obstructive sleep apnea are common. continuous passive airway pressure (CPAP) is an authorized treatment for this type of apnea but still the recommendations of changing lifestyles are the suggested cornerstone therapies especially in obese males
Detailed description
Forty males with metabolic syndrome, sexual impotence (erectile dysfunction), and obstructive sleep apnea will be randomized to control group (CPAP will be applied in this group that will contain 20 males, CPAP will be applied five days weekly during night-sleeping for 4 hours for 12 weeks ) and study 20-patient group (also CPAP will be applied with the same protocol of control group plus lifestyle changes that will contain 3-session per-week 40-minute treadmill exercising and low-caloric/dietary 12-week restriction)
Interventions
BEHAVIORALlifestyle changing plus CPAP
20 males with metabolic syndrome, sexual impotence (erectile dysfunction), and obstructive sleep apnea will be in this group (CPAP will be applied in this group that will contain 20 males, CPAP will be applied five days weekly during night-sleeping for 4 hours for 12 weeks plus lifestyle changes that will contain 3-session per-week 40-minute treadmill exercising and low-caloric/dietary 12-week restriction.
OTHERCPAP
20 males with metabolic syndrome, sexual impotence (erectile dysfunction), and obstructive sleep apnea will be in this group. in this group CPAP will be applied five days weekly during night-sleeping for 4 hours for 12 weeks
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
40 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* moderate and severe obstructive sleep apnea * erectile dysfunction (mild and moderate) * metabolic syndrome men
Exclusion criteria
* cardiac patients * psychiatric men * autoimmune diseased men * renal diseased men
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| international index of erectile function (five-item Arabic version) | it will be measured after 12 weeks | a questionnaire that will assess erectile function |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| neck circumference | It will be measured after 12 weeks | it will be measured by a tape |
| index of apnea and hypopnea | It will be measured after 12 weeks | it will assess number of events of apnea and hypapnea during one-hour sleeping |
| ration of oxygen desaturation per hour | It will be measured after 12 weeks | it will assess ratio of oxygen desaturation |
| Epworth sleepiness scale | It will be measured after 12 weeks | it will assess daytime sleepiness |
| body mass index | it will be measured after 12 weeks | it will be measured on empty stomach |
| fasting glycemia | It will be measured after 12 weeks | it will be assessed by blood glucose meter |
| high density lipoprotein | It will be measured after 12 weeks | it will be assessed in serum |
| triglycerides | It will be measured after 12 weeks | it will be assessed in serum |
| systolic blood pressure | It will be measured after 12 weeks | it will be measured by manual sphygmomanometer |
| diastolic blood pressure | It will be measured after 12 weeks | it will be measured by manual sphygmomanometer |
| waist circumference | It will be measured after 12 weeks | it will be assessed at the level of umbilicus |
Countries
Egypt
Contacts
Primary ContactAli MA Ismail, lecturer
Backup ContactAhmed MA Elfahl
Outcome results
None listed