OSAS
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1: Voluntarily participate in this clinical trial, provide informed consent and sign the informed consent form 2: Complies with the diagnosis of obstructive sleep apnea hypopnea syndrome 3: Determine the severity of the condition as mild to moderate based on the apnea hypopnea index (5 <= AHI <= 30 times/h) 4: Age range of 18 to 65 years old (including 18 and 65 years old), gender not limited
Exclusion criteria
Exclusion criteria: 1: Other diseases that affect breathing or sleep, such as narcolepsy, restless leg syndrome, cyclic leg movement syndrome during sleep, central sleep apnea syndrome, chronic obstructive pulmonary disease, interstitial lung disease, bronchial asthma, and pulmonary hypopnea; Combining severe primary diseases such as heart, brain, lung, liver, kidney, nervous system, and hematopoietic system, or severe OSAS (AHI>30 times/h) 2: Combined with severe nasal septum deviation, nasal polyps, nasal tumors, pharyngeal tumors, mandibular retrognathia, submandibular malformations, and third degree tonsillar enlargement 3: Prior to enrollment, patients underwent surgical treatments such as palatoplasty and pharyngoplasty that have therapeutic effects on OSAS 4: Have taken sedatives, hypnotics, central nervous system stimulants, or other drugs that cause or worsen this disease within one week before enrollment 5: Receiving continuous positive airway pressure (CPAP) and orthodontic treatment 6: Multi channel sleep monitoring with minimum blood oxygen saturation40kg/m^2 8: Having intellectual or mental disabilities 9: Participated in other clinical trials within the past 3 months 10: According to the researchers' judgment, patients who are deemed unsuitable to participate in this trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| reduction of apnea hypopnea index (AHI); | — |
Secondary
| Measure | Time frame |
|---|---|
| hypoxic burden;Awakening Index;Total sleep time;Sleep efficiency;Snoring index;Oxygen depletion index;Epworth Sleepiness Scale;snoring frequency and intensity;Pittsburgh Sleep Quality Index;GAD-7 and PHQ-9;Therapeutic self-efficacy assessment;Quebecsleepquestionnaire,QSQ; | — |
Countries
China
Contacts
Southern Medical University Southern Hospital, 1838 Guangzhou Avenue North, Baiyun District, Guangzhou City, Guangdong Province