Implant Supported Oral Appliance Treatment of OSA

NCT03362671 | Terminated

• 1 other identifier: 14G31862
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

Mandibular advancing oral appliances (OAm) are an effective and increasingly common treatment modality for the management of obstructive sleep apnea (OSA) in adults. The effectiveness of OAm therapy, however, is dependent on a high level of patient adherence, which may be negatively impacted by treatment side effects - the most significant of which are occlusal changes and tooth movement. The proposed pilot study will evaluate the efficacy of a novel implant supported OAm in 10 OSA patients who have already been successfully treated with a traditional OAm. The study will compare OSA specific outcomes with traditional OAm use against novel oral appliance use after one month. This study could potentially validate the novel design features of an effective treatment option for OSA that does not result in tooth movement, which is a significant side effect shared by all existing OAm devices. Ultimately, this study could lead to increased treatment adherence and better OSA patient health outcomes in the future.

Conditions

Obstructive Sleep Apnea

Keywords

OSA; Mandibular Advancement Splint; Oral Appliance; Treatment; Orthodontic Implants

Outcome Measures

Primary Outcomes (1)

• Change in Apnea-Hypopnea Index (AHI)

  Indication of the severity of sleep apnea. The AHI is calculated by dividing the number of apnea events by the number of hours of sleep. This outcome will assess the change in AHI over time.

  Data collected at 0, and 1 months after initiation of treatment with the new appliance.

Secondary Outcomes (10)

• Daytime Sleepiness

  Data collected at 0, 1, and 4 months after initiation of treatment with the new appliance.

• Arterial Oxygen Saturation

  Data collected at 0, 1, and 4 months after initiation of treatment with the new appliance.

• Treatment Adherence

  Data will be collected by the research team 4 months after initiation of treatment with the new appliance.

• Patient Experience

  Data collected 1 and 4 months after initiation of treatment with the new appliance.

• Mini Implant Side Effects - Mobility

  Data collected at 1 week, 1 month and 4 months after initiation of treatment with the new appliance.

Study Arms (1)

Treatment Group

EXPERIMENTAL

Participants will be treated with a novel experimental implant supported mandibular advancement oral appliance, which uniquely attaches to orthodontic mini implants (OMIs) in the jaw. Participants will be fitted with OMIs per standard clinical practice prior to treatment with the novel oral appliance.

Device: Implant Supported Mandibular Advancement Oral Appliance; Device: Orthodontic Mini Implant

Interventions

Implant Supported Mandibular Advancement Oral Appliance DEVICE

This device is a novel oral appliance that attached to orthodontic mini implants in the jaw and is designed to keep the jaw in an advanced position, opening the upper airway during sleep.

Treatment Group

Orthodontic Mini Implant DEVICE

Small titanium devices that are fixed to the bone for the purpose of enhancing anchorage of other orthodontic devices.

Also known as: Temporary Anchorage Devices (TADs)

Treatment Group

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Currently receive or have previously received successful OSA treatment with an OAm;
• Age 25 - 65 years old, who are able to freely provide informed consent;
• Body Mass Index (BMI) ≤ 35;
• Apnea-Hypopnea Index (AHI) within the range 5≤AHI≤50 documented with polysomnography in the last 2 years \*\*\*OR\*\*\*
• Respiratory Disturbance Index (RDI) within the range 20 ≤ RDI ≤ 50 documented with Level III portable sleep test \*\*\*OR\*\*\*
• Oxygen Desaturation Index (ODI) ≥ 10

You may not qualify if:

• The patient is excluded if it meets any of the following criteria:
• Extensive periodontal disease;
• Bleeding disorder;
• Bone metabolic disorder
• Immunocompromised
• Diabetes mellitus
• Xerostomia
• Titanium allergy
• Insufficient vertical opening to accommodate treatment with OAm;
• Pregnancy (if a participant becomes pregnant during the trial, the participant will be withdrawn from the study).
• Uncontrolled congestive heart failure (defined as a prior clinical diagnosis, an ejection cut-off of 40% or clinical sign in the opinion of a primary care physician or cardiologist) that makes it unsafe in the opinion of the investigators for the subject to participate in the trial;
• Coronary artery disease unless stable for at least 6 months and considered by the investigators to have a stable disease;
• Any history of angina, myocardial infarction or stroke;
• Any history of major depressive disorder along with current moderate-severe disease;
• Active cancer management (unless in remission for more than 1 year);

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

University of British Columbia

Vancouver, British Columbia, V6T 1Z3, Canada

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

• Benjamin T Pliska, DDS

  University British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 23, 2017
• First Posted: December 5, 2017
• Study Start: April 1, 2018
• Primary Completion: June 11, 2019
• Study Completion: September 11, 2019
• Last Updated: November 22, 2022

Record last verified: 2022-11

Locations

CA (1)