New titration method for treating sleep apnea with a mandibular device
A New Objective Titration Procedure Using Remotely Intelligent Sleep Monitoring System for the Treatment of Mandibular Advancement Device in OSAHS Patients
This study is testing a new way to adjust a mouth device for people with sleep apnea to see if it works better and faster than the usual method.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Beijing Jishuitan Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing) |
| Trial ID | NCT06424405 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate a new objective titration procedure for patients with obstructive sleep apnea hypopnea syndrome (OSAHS) using a mandibular advancement device (MAD). The study will compare the efficacy and efficiency of this new procedure, which utilizes a remotely intelligent sleep monitoring system (RISMS), against the traditional subjective titration method. Patients diagnosed with OSAHS will be recruited and assigned to one of the two titration procedures to determine the optimal mandibular protrusion. The trial will assess the effectiveness of MAD therapy, the time taken for titration, and improvements in patient-reported symptoms.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 70 with a diagnosis of OSAHS and an apnea-hypopnea index (AHI) of 15 or greater.
Not a fit: Patients with active periodontal issues, severe systemic diseases, or those who are edentulous may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective and efficient treatment options for patients with obstructive sleep apnea.
How similar studies have performed: While the approach of using objective titration methods is gaining interest, this specific application with RISMS is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * OSAHS patients with AHI≥15 * 18≤age≤70 years; * Subject is capable of giving informed consent * refusal of or noncompliance with CPAP (continuous positive airway pressure) or unwilling to undergo upper airway surgery * Normal clinical, periodontal and temporomandibular joint examination Exclusion Criteria: * Active periodontal problems including tooth mobility * active temporomandibular joint dysfunction * Edentulous patients or Insufficient teeth to support MAD * patients with severe unstable systemic diseases or suffering from psychiatric disorders * Enlarged palatine tonsils (Friedman grade IV tonsils)
Where this trial is running
Beijing, Beijing
- Beijing Jishuitan Hospetal — Beijing, Beijing, China (Recruiting)
Study contacts
- Study coordinator: Huijia HJ Lei, doctor
- Email: leihuijia2006@126.com
- Phone: 8601058516688
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.