Clinical Study of Customized Adjustable Oral in Treatment of Patients With Obstructive Sleep Apnea Syndrome

NCT03729895 | Unknown

• 1 other identifier: KY-2018-5-10
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The oral appliances (OAs) are considered to be an effective treatment modality for snoring and various forms of obstructive sleep apnea syndrome (OSAS). They facilitate the displacement of the mandible anteriorly and widen the upper airway during sleep. Lateral cephalometry has been used for the two-dimensional evaluation of upper airway form with several limits.The purpose of present study is to investigate an accurate three-dimensional (3D) volume analyses with cone beam computed tomography (CBCT) scans to confirm the effects of OAs on the upper airway in patients with OSAS.The investigators aim to enroll twenty-four patients with mild,moderate or severe OSAS, intolerant to continuous positive air pressure therapy and rejection a surgical approach,who will be treated with adjustable customized OAs and evaluated with CBCT and polysomnography. Upper airway form was examined and the volume was measured in two different areas. Specific planes have been considered to match the data and calculate the benefit obtained with therapy.

Conditions

Obstructive Sleep Apnea Syndrome

Keywords

Orthodontic Appliances; Cone-Beam Computed Tomography

Outcome Measures

Primary Outcomes (1)

• change in apnea hypopnea index(AHI)

  the change from apneas hypopneas per hour of sleep registration of the subjects fitted with oral appliance at 3,6 and 10 months

  3,6 and 10 months

Secondary Outcomes (4)

• change in apnea index(AI)

  3,6 and 10 months

• change in lowest blood oxygen saturation

  3,6 and 10 months

• change in minimal volume/transverse diameter/sagittal diameter/cross-sectional area of the velopharyngeal segment of the subjects

  3,6 and 10 months

• change in minimal volume/transverse diameter/sagittal diameter/cross-sectional area of the oropharyngeal segment of upper airway

  3,6 and 10 months

Study Arms (1)

patients with OSAS in different degrees

EXPERIMENTAL

OSAS patients will be treated with an adjustable oral appliance and evaluated with cone-beam computed tomography and polysomnography.

Device: Adjustable Oral Appliance

Interventions

Adjustable Oral Appliance DEVICE

Adjustable Oral Appliance consist of plastic maxillary occlusal splint，mandible occlusal splint and adjustable connecting rod.It could offer a non-invasive form of treatment but also achieve a good therapeutic effect

patients with OSAS in different degrees

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Apnea-hypopnea index(AHI)between 5/h and 45/h
• Aged between 18 and 50 years old
• Intolerance to continuous positive airway pressure or surgery
• Body Mass Index(BMI) \<35kg/m
• Those who are competent to give written informed consent
• Have adequate tooth support to retain the oral appliance

You may not qualify if:

• Previous or current treatment for OSAS
• Presence of respiratory/sleep disorders other than obstructive sleep apnea
• Medication usage that could influence respiration or sleep
• Concurrent unstable cardiovascular disease,neurological or mental disorders
• Active periodontal endodontic disease or open bite
• Temporomandibular joint disorders
• Loss of posterior dental support to undermine the retention of oral appliance
• Pregnancy

Sponsors & Collaborators

• Affiliated Hospital to Academy of Military Medical Sciences: lead

Study Sites (1)

Chiese PLA 307 hospital

Beijing, Beijing Municipality, 100071, China

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• rongjian Lu, doctor

  Chinese PLA 307 Hospital

  STUDY DIRECTOR

Central Study Contacts

biao Guo, master

CONTACT

0086-010-66947095; 418406096@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Twenty-four patients diagnosed with OSAS in different degrees,who cannot tolerate continuous positive air pressure use and reject a surgical approach, were treated with adjustable customized oral appliances and evaluated with cone-beam computed tomography and polysomnography.

Study Record Dates

• First Submitted: September 24, 2018
• First Posted: November 5, 2018
• Study Start: November 1, 2018
• Primary Completion: September 1, 2019
• Study Completion: October 1, 2019
• Last Updated: November 5, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)