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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
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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| study group | Experimental | 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. |
|
| control group | Active Comparator | 20 males with metabolic syndrome, sexual impotence (erectile dysfunction), and obstructive sleep apnea will be included this control group. in this group CPAP will be applied five days weekly during night-sleeping for 4 hours for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lifestyle changing plus CPAP | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| international index of erectile function (five-item Arabic version) | a questionnaire that will assess erectile function | it will be measured after 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| index of apnea and hypopnea | it will assess number of events of apnea and hypapnea during one-hour sleeping | It will be measured after 12 weeks |
| ration of oxygen desaturation per hour | it will assess ratio of oxygen desaturation |
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Inclusion Criteria:
Exclusion Criteria:
self-representation of gender identity.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ali MA Ismail, lecturer | Contact | 01005154209 | ali.mohamed@pt.cu.edu.eg | |
| Ahmed MA Elfahl | Contact | ahmedelfahl2021@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Ali MA Ismail, lecturer | Cairo University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of physical therapy | Recruiting | Giza | Dokki | Egypt |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D007172 | Erectile Dysfunction |
| D024821 | Metabolic Syndrome |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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|
| CPAP | Other | 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 |
|
| It will be measured after 12 weeks |
| Epworth sleepiness scale | it will assess daytime sleepiness | It will be measured after 12 weeks |
| body mass index | it will be measured on empty stomach | it will be measured after 12 weeks |
| neck circumference | it will be measured by a tape | It will be measured after 12 weeks |
| fasting glycemia | it will be assessed by blood glucose meter | It will be measured after 12 weeks |
| high density lipoprotein | it will be assessed in serum | It will be measured after 12 weeks |
| triglycerides | it will be assessed in serum | It will be measured after 12 weeks |
| systolic blood pressure | it will be measured by manual sphygmomanometer | It will be measured after 12 weeks |
| diastolic blood pressure | it will be measured by manual sphygmomanometer | It will be measured after 12 weeks |
| waist circumference | it will be assessed at the level of umbilicus | It will be measured after 12 weeks |
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D012735 | Sexual Dysfunction, Physiological |
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |