Effects of Two Different Amounts of Mandibular Protrusion in OSA Patients Using Mandibular Advancement Appliance

NCT04079153 | Unknown

• 1 other identifier: 2019421-7342
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Obstructive sleep apnea (OSA) is a complex disease associated with repeated closure of the upper airway during sleep which causes excessive daytime sleepiness. Daytime sleepiness can affects daytime performance undesirably and reduces driving performance causing an increased risk for accidents. It can also lead to high blood pressure, strokes, and eventually death. Until now, there is no standardize value for the jaw advancement for the mandibular advancement appliance. It was found that when comparing the jaw advancement amount of 50% and above 50%, there is no additional efficacy. Efficacy of jaw advancement below 50% is lacking. Patients usually experience more complications with more advancement, there the investigators need to study the optimal mandibular advancement with least complication to the patients.

Conditions

Obstructive Sleep Apnea

Keywords

mandibular advancement appliance, protrusion

Outcome Measures

Primary Outcomes (1)

• Change in Apnea-hypopnea index (AHI)

  Apnea Hypopnea Index (AHI) is one of the parameters obtained from polysomnography(PSG) to determine the severity of obstructive sleep apnoea. The AHI is the number of apneas or hypopneas recorded during the study per hour of sleep. It is generally expressed as the number of events per hour. Based on the AHI, the severity of OSA is classified as follows: None/Minimal: AHI \< 5 per hour; Mild: AHI ≥ 5, but \< 15 per hour; Moderate: AHI ≥ 15, but \< 30 per hour and Severe: AHI ≥ 30 per hour. For comparison with other studies, we will also calculate the percentage of patients achieving: (1) reduction in AHI ≥50%; (2) AHI \<10; and (3) AHI \<5, together with the success criteria defining complete response(CR) as resolution of symptoms and outcome AHI \<5, and partial response(PR) as improvement of symptoms and reduction in AHI ≥50% but outcome AHI ≥5. Failure(F) was defined as a reduction in AHI \<50% and ⁄ or ongoing symptoms.

  6 months

Secondary Outcomes (8)

• Change in Blood Pressure

  6 months

• Change in Epworth Sleepiness Scale (ESS)

  6 months

• Change in minimum oxygen saturation (MinSaO2)

  6 months

• Change in Quality of Life: Calgary Sleep Apnea Quality of Life Index (SAQLI)

  6 months

• Compliance of wearing the mandibular advancement appliance(MAA)

  6 months

Study Arms (2)

25% of maximal mandibular advancement

ACTIVE COMPARATOR

25% of maximal mandibular advancement of individual protrusion range

Device: Mandibular advancement Appliance

50% of maximal mandibular advancement

ACTIVE COMPARATOR

50% of maximal mandibular advancement of individual protrusion range

Device: Mandibular advancement Appliance

Interventions

Mandibular advancement Appliance DEVICE

Advances the mandible at desired range at a fixed vertical dimension

25% of maximal mandibular advancement; 50% of maximal mandibular advancement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Mild and moderate OSA patients who are keen on MAA
• Severe OSA who had refuse CPAP
• Aged 18 years and older
• Without any form of prior treatment
• Absence of any structural obstruction examined by otolaryngologist
• Sufficient set of teeth to hold the appliance

You may not qualify if:

• Presence of periodontal disease
• Exaggerated gag reflex and temporomandibular joint disorder
• Significant co-morbidity that could endanger the patient's health
• Any psychiatric or neurological diseases previously known that could impair the compliance
• Any medication intake that can influence sleep
• Co-existing sleep disorders other than OSA for instance insomnia, central sleep apnea and etc
• Pregnant candidates

Sponsors & Collaborators

• University of Malaya: lead

Study Sites (1)

Faculty of Dentistry, University of Malaya

Petaling Jaya, Kuala Lumpur, 50603, Malaysia

RECRUITING

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

• Lau May Nak

  University of Malaya

  STUDY DIRECTOR

Central Study Contacts

Chin Mei H'uah

CONTACT

0172542296; chinmeihuah@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Patients will be blinded to the intervention allocation and intervention group. A single orthodontic resident will treat all the patients, and one dental technician will construct all the appliances. The clinician, however, is unable to be blinded due to the need to prescribe the MAA as being randomized. Data collection and analysis will be done by the orthodontic resident. Blinding during data collection will not possible but after data collection, all the data will be coded before being processed and analysed, ensuring blinding of this stage of study. Sleep technician and physician who respectively carried out and analysed the polysomnography will be blinded to the treatment assignment. Statistician who analysed the data will also blinded to the group of treatment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postgraduate Student

Model Details: Group A will be assigned for intervention group, whereby patients will receive their MAA set at 25% of mandibular maximal protrusion while Group B will be assigned for control group, whereby patients will receive their MAA set at 50% of mandibular maximal protrusion.

Study Record Dates

• First Submitted: August 28, 2019
• First Posted: September 6, 2019
• Study Start: August 1, 2019
• Primary Completion: May 31, 2022
• Study Completion: May 31, 2022
• Last Updated: September 29, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)