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Clinical study of multidisciplinary combined diagnosis and treatment of male erectile dysfunction combined with obstructive sleep apnea hypopnea syndrome

Clinical study of multidisciplinary combined diagnosis and treatment of male erectile dysfunction combined with obstructive sleep apnea hypopnea syndrome

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200062020
Enrollment
Unknown
Registered
2022-07-19
Start date
2022-08-01
Completion date
Unknown
Last updated
2023-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Erectile dysfunction and obstructive sleep apnea-hypopnea syndrome in men

Interventions

A:The OSAHS standard treatment plan combined with the ED treatment plan was adopted
the OSAHS treatment mainly uses a ventilator for nasal continuous positive airway pressure (CPAP) treatment, the pressure setting starts from 4cm H2O, and the patient adapts to gradually increase the
B:Only treat patients with OSAHS standard treatment, namely CPAP treatment, and require patients to at least ensure that more than 70% of the nights receive CPAP treatment and use it for more than 4 h
C:Only the patients were given standard ED treatment, that is, LIPUS treatment 3 times a week for 2 consecutive weeks

Sponsors

Tianjin Medical University General Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
20 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Age 20-60 years old, male; 2. General health, with stable heterosexual partners for more than 3 months; 3. Diagnosed with obstructive sleep apnea-hypopnea syndrome (OSAHS) by the Department of Respiratory Medicine; 4. Able to tolerate nasal continuous positive airway pressure (CPAP) treatment; 5. Diagnosed as ED by nocturnal penile erection hardness (NPTR) test; 6. No PDE5-i or other ED treatment was used within 2 weeks before the grouping, and there was no obvious drug contraindication; 7. The patients voluntarily agreed to participate in this study and signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1. ED caused by serious neurological or serious mental and psychological factors; 2. Those who have previously undergone radical prostatectomy, pelvic surgery or radical prostatectomy and other surgeries affecting erectile function; 3. Any unstable medical, spinal cord injury, abnormal penis anatomy; 4. Those with obstruction of the penile artery or cavernous artery; 5. Those who are recovering from cancer in the past year; 6. Clinically significant chronic blood system diseases, or severe respiratory, digestive, and central nervous system diseases; 7. Those who have confirmed penile hemangioma or cavernous fibrosis; 8. Patients with hypertension with poor blood pressure control (systolic blood pressure = 160 mmHg and/or diastolic blood pressure = 100 mmHg after treatment); 9. Use of anti-androgens and androgen drugs; 10. Postoperative radiotherapy in the pelvic region; 11. Patients with coagulation disorders and using anticoagulants; 12. Have participated in any other medical device or drug clinical research within the past 3 months; 13. Patients who cannot tolerate and/or are unwilling to receive CPAP therapy; 14. Those with a history of chronic mental illness, heavy alcoholism, drug abuse, taking antipsychotic drugs (including sleeping pills and stimulants), and circadian rhythm disorders; 15. Obstructive pulmonary disease and upper airway tumor or disease that compresses the airway; 16. Patients deemed unsuitable for participation in this trial by other investigators.

Design outcomes

Primary

MeasureTime frame
Polysomnography (PSG) test results;Penile angiography and penile electrophysiology;

Countries

China

Contacts

Public ContactXiaoqiang Liu
xiaoqiangliu1@163.com+86 13820915038

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026