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A single center, randomized, placebo-controlled parallel controlled clinical trial evaluating the efficacy and safety of oral and facial muscle function training (OMT) in the treatment of mild to moderate obstructive sleep apnea syndrome

A single center, randomized, placebo-controlled parallel controlled clinical trial evaluating the efficacy and safety of oral and facial muscle function training (OMT) in the treatment of mild to moderate obstructive sleep apnea syndrome

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500097284
Enrollment
Unknown
Registered
2025-02-17
Start date
2025-03-01
Completion date
Unknown
Last updated
2025-02-24

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

Conditions

OSAS

Interventions

Experimental group:Oral and facial muscle training
control group:Deep breathing exercise

Sponsors

Southern Medical University Southern Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

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

MeasureTime frame
reduction of apnea hypopnea index (AHI);

Secondary

MeasureTime 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

Public ContactYuan Feng

Southern Medical University Southern Hospital, 1838 Guangzhou Avenue North, Baiyun District, Guangzhou City, Guangdong Province

yuanstar@126.com+86 138 2502 7946

Outcome results

None listed

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