Therapeutic Efficiency of Mandibular Advancement Device Using Smartphone Sleep Applications and Pulse Oximeter

June 8, 2020 updated by: Bahadır EZMEK

Therapeutic Efficiency Analyses of Mandibular Advancement Devices on Obstructive Sleep Apnea Using Polysomnography, Smartphone Sleep Applications, and Simple Pulse Oximeter

An observational clinical trial in a single centre. The objective of this study was to determine the efficacy of mandibular advancement device (MAD) therapy on snoring intensity, frequency, and oxygen desaturation periods in mild-moderate obstructive sleep apnea (OSA) patients with snoring problems. Totally, 18 mild-moderate OSA patients (8 females and 10 males) with subjective snoring complaint were selected. Each patient's diagnostic polysomnographic analysis (PSG) was accepted as initial PSG values. Each patient was subjected simple pulse oximeter (SPO) and smartphone sleep application (SSA) at 3 different nights at home. Diagnostic mean values of oxygen desaturation index (obtained by using SPO), snoring intensity score (obtained by using SSA), and snoring percentage (obtained by using SSA) were recorded. Non-titratable-customized MAD with 60-75% of maximal mandibular protrusion were fabricated. The patients were instructed to wear their MAD every night. SPO and SSA measurement were repeated at the 1st, 4th, 12th, and 24th week of the treatment process. At the 24th week of treatment, The PSG were repeated and all PSG, SPO, and SSA values were compared with initial diagnostic values.

Study Overview

Study Type

Observational

Enrollment (Actual)

18

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Mild-moderate obstructive sleep apnea patients were referred Department of Prosthodontics, Gülhane Faculty of Dentistry for oral appliance treatment

Description

Inclusion Criteria:

  • mild-moderate OSA patients with subjective snoring complaints

Exclusion Criteria:

  • Severe OSA
  • Undergone previous surgical therapy for SS or OSA
  • High-risk of cardiovascular, respiratory, neurological, or psychiatric disorders
  • Inadequate dental anchor for MAD treatment
  • Temporomandibular joint dysfunction
  • Angle Class III maxillomandibular relation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Mild-moderate OSA patients for MAD treatment
Patients are classified as mild Obstructive Sleep Apnea (OSA) if they have between 5-15 Apnea-Hypopnea Index, moderate if they have between 15-30, and severe if they have >30, as measured by Polysomnography (Epstein LJ, Kristo D, Strollo PJ, et al. 2009). The principal treatment methodology for OSA patients is positive airway pressure. In patients with mild to moderate OSA, oral appliances such as mandibular advancement devices (MAD) is alternately indicated (Ramar K, Dort LC, Katz SG, et al. 2015) The American Academy of Dental Sleep Medicine (Ramar K, Dort LC, Katz SG, et al. 2015) recommended titratable-customized MADs for patient comfort and the ability to permit modifications in the amount of mandibular protrusion for treatment efficacy. However, Aarab et al (Aarab G, Lobbezoo F, Hamburger HL, Naeije M. 2010) demonstrated similar therapeutic efficiency of non-titratable-customized MADs in the treatment of OSA
The most comfortable protruded mandibular position situated between 60-75% of MMPV was determined according to patient response with 6mm of the vertical interocclusal dimension between maxillary and mandibular central incisors and registered. The upper and lower acrylic resin splints were secured to each other in the posterior region with auto polymerizing acrylic resin and NTC-MADs were obtained. The patients were instructed to wear their non-titratable-customized mandibular advancement device every night.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline Apnea-Hypopnea Index (AHI) at 6 months
Time Frame: at baseline and in 6 months
AHI was defined as total number of apnea or hypopnea events which lasts for at least ten seconds per hour during full nigth polysomnography (PSG) and accepted to be the main physiological sleep parameter in the present study. The AHI values were used for the evaluation of the severity of OSA and the MAD's treatment success in OSA patients
at baseline and in 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oxygen-desaturation index (ODI)
Time Frame: at baseline and in 6 months
ODI was used to evaluate the desaturation fluctuations during full night PSG. ODI is defined as 3-4% decrease in oxygen saturation per hour.
at baseline and in 6 months
Snoring index (SI)
Time Frame: at baseline and in 6 months
SI was used to evaluate snoring events per hour during PSG
at baseline and in 6 months
Simple pulse oximeter (SPO)/ODI
Time Frame: at baseline and 1, 4, 12, and 24 week of MAD treatment
SPO/ODI was used to evaluate the desaturation fluctuations during sleep in-home environment by using simple pulse oximeter device
at baseline and 1, 4, 12, and 24 week of MAD treatment
Smartphone sleep application (SSA)/snoring intensity score (SIS)
Time Frame: at baseline and 1, 4, 12, and 24 week of MAD treatment
SSA/SIS was used to evaluate snoring intensity that was calculated by SSA during sleep in-home environment. No information exists about how to calibrate the SSA to calculate SIS
at baseline and 1, 4, 12, and 24 week of MAD treatment
SSA/snoring percentage (SP)
Time Frame: at baseline and 1, 4, 12, and 24 week of MAD treatment
SSA/SP was the ratio of total snoring time to total sleep time that was calculated by SSA during sleep in-home environment. No information exists about how to calibrate the SSA to calculate SP.
at baseline and 1, 4, 12, and 24 week of MAD treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Study Chair: Bulent Piskin, Prof., Technology of Dental Prosthodontics, Kapadokya University, Turkey

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 24, 2015

Primary Completion (ACTUAL)

December 24, 2017

Study Completion (ACTUAL)

December 24, 2017

Study Registration Dates

First Submitted

June 4, 2020

First Submitted That Met QC Criteria

June 8, 2020

First Posted (ACTUAL)

June 11, 2020

Study Record Updates

Last Update Posted (ACTUAL)

June 11, 2020

Last Update Submitted That Met QC Criteria

June 8, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Obstructive Sleep Apnea

Clinical Trials on Non-titratable-customized mandibular advancement device

3
Subscribe