New titration method for treating sleep apnea with a mandibular device

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Beijing Jishuitan Hospetal
  Beijing, Beijing, China Recruiting

Study contacts

• Study coordinator: Huijia HJ Lei, doctor
• Email: leihuijia2006@126.com
• Phone: 8601058516688

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.