Obstructive Sleep Apnea
Conditions
Interventions
Experimental group:Treating OSA with an oral appliance
Sponsors
Beijing Tsinghua Changgung Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Participants meeting all of the following criteria were included in the study: 1. Adults aged 18 years or older; 2. Diagnosis of obstructive sleep apnea (OSA) according to the Multidisciplinary Guideline for the Diagnosis and Treatment of Adult Obstructive Sleep Apnea, fulfilling either (A + B) or C: A. Presence of at least one of the following: (1).Complaints of sleepiness, non-restorative sleep, fatigue, or insomnia; (2).Awakening from sleep due to breath holding, choking, or gasping; (3).Habitual snoring, witnessed apnea, or both during sleep as reported by a bed partner or other observers; (4).Previously diagnosed hypertension, mood disorders, cognitive impairment, coronary artery disease, cerebrovascular disease, congestive heart failure, atrial fibrillation, or type 2 diabetes mellitus. B. Polysomnography (PSG) demonstrating >=5 respiratory events per hour during monitoring, including obstructive apnea, mixed apnea, hypopnea, and respiratory effort-related arousals (RERAs). C.PSG demonstrating >=15 respiratory events per hour during monitoring, including obstructive apnea, mixed apnea, hypopnea, and RERAs. 3. Provision of written informed consent for participation in the study; 4. According to the American Academy of Sleep Medicine guideline, Clinical Practice Guideline for the Treatment of Obstructive Sleep Apnea and Snoring with Oral Appliance Therapy: An Update for 2015, priority was given to enrolling patients with mild-to-moderate OSA, as well as patients with severe OSA who were intolerant of or refused continuous positive airway pressure (CPAP) therapy.
Exclusion criteria
Exclusion criteria: Participants meeting any of the following criteria were excluded from the study: 1. Contraindications to oral appliance (OA) therapy, including insufficient dentition for appliance retention, acute temporomandibular joint pain during mouth opening, severe periodontal disease, or edge-to-edge incisor relationship; 2. Presence of neuromuscular disorders, chronic obstructive pulmonary disease (COPD), severe cardiovascular or cerebrovascular disease, hemodynamic instability, claustrophobia, implanted cardiac pacemakers, metallic implants in the head and neck region, cerebrospinal fluid rhinorrhea, or other contraindications to the relevant examinations or treatments; 3. Hereditary diseases associated with craniofacial and/or upper airway structural abnormalities, history of nasal, pharyngeal, oral, or maxillofacial surgery, or speech disorders; 4. Recent upper respiratory tract infection; 5. Presence of other severe sleep-related breathing disorders (e.g., central sleep apnea, parasomnias, or severe insomnia); 6. Use of benzodiazepines and/or antidepressant medications; 7. History of psychiatric disorders, including alcohol abuse; 8. A body mass index (BMI) fluctuation exceeding 5% before and after OA therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Oxygen Desaturation Index;Effective rate(AHI50%); | — |
Secondary
| Measure | Time frame |
|---|---|
| Apnea-Hypopnea Index;Obstructive Apnea-Hypopnea Index;Mean Oxygen Saturation;Minimum Oxygen Saturation;Epworth Sleepiness Scale score;Psychomotor Vigilance Task score;36-Item Short Form Health Survey score;Maxillofacial-upper airway soft tissue parameters(tongue, soft palate, medial pterygoid muscle and parapharyngeal fat space );Skeletal structure parameters(maxilla, mandible, hyoid bone and thyroid cartilage);Airflow field measurement parameters(airway resistance, airflow velocity and wall shear stress); | — |
Countries
China
Contacts
Public ContactJingying Ye
Beijing Tsinghua Changgung Hospital
Outcome results
None listed