- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04427111
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
Status
Completed
Conditions
Intervention / Treatment
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
- Ramar K, Dort LC, Katz SG, Lettieri CJ, Harrod CG, Thomas SM, Chervin RD. Clinical Practice Guideline for the Treatment of Obstructive Sleep Apnea and Snoring with Oral Appliance Therapy: An Update for 2015. J Clin Sleep Med. 2015 Jul 15;11(7):773-827. doi: 10.5664/jcsm.4858.
- Aarab G, Lobbezoo F, Hamburger HL, Naeije M. Effects of an oral appliance with different mandibular protrusion positions at a constant vertical dimension on obstructive sleep apnea. Clin Oral Investig. 2010 Jun;14(3):339-45. doi: 10.1007/s00784-009-0298-9. Epub 2009 Jun 18.
- Zhou J, Liu YH. A randomised titrated crossover study comparing two oral appliances in the treatment for mild to moderate obstructive sleep apnoea/hypopnoea syndrome. J Oral Rehabil. 2012 Dec;39(12):914-22. doi: 10.1111/joor.12006. Epub 2012 Sep 27.
- Fiz JA, Jane R, Sola-Soler J, Abad J, Garcia MA, Morera J. Continuous analysis and monitoring of snores and their relationship to the apnea-hypopnea index. Laryngoscope. 2010 Apr;120(4):854-62. doi: 10.1002/lary.20815.
- Umemoto G, Toyoshima H, Yamaguchi Y, Aoyagi N, Yoshimura C, Funakoshi K. Therapeutic Efficacy of Twin-Block and Fixed Oral Appliances in Patients with Obstructive Sleep Apnea Syndrome. J Prosthodont. 2019 Feb;28(2):e830-e836. doi: 10.1111/jopr.12619. Epub 2017 Apr 19.
- Isacsson G, Fodor C, Sturebrand M. Obstructive sleep apnea treated with custom-made bibloc and monobloc oral appliances: a retrospective comparative study. Sleep Breath. 2017 Mar;21(1):93-100. doi: 10.1007/s11325-016-1377-1. Epub 2016 Jul 5.
- Jobin V, Mayer P, Bellemare F. Predictive value of automated oxygen saturation analysis for the diagnosis and treatment of obstructive sleep apnoea in a home-based setting. Thorax. 2007 May;62(5):422-7. doi: 10.1136/thx.2006.061234. Epub 2007 Jan 24.
- Ernst G, Bosio M, Salvado A, Dibur E, Nigro C, Borsini E. Difference between apnea-hypopnea index (AHI) and oxygen desaturation index (ODI): proportional increase associated with degree of obesity. Sleep Breath. 2016 Dec;20(4):1175-1183. doi: 10.1007/s11325-016-1330-3. Epub 2016 Mar 30.
- Camacho M, Robertson M, Abdullatif J, Certal V, Kram YA, Ruoff CM, Brietzke SE, Capasso R. Smartphone apps for snoring. J Laryngol Otol. 2015 Oct;129(10):974-9. doi: 10.1017/S0022215115001978. Epub 2015 Sep 3.
- Stippig A, Hubers U, Emerich M. Apps in sleep medicine. Sleep Breath. 2015 Mar;19(1):411-7. doi: 10.1007/s11325-014-1009-6. Epub 2014 Jun 3.
- Walker-Engstrom ML, Ringqvist I, Vestling O, Wilhelmsson B, Tegelberg A. A prospective randomized study comparing two different degrees of mandibular advancement with a dental appliance in treatment of severe obstructive sleep apnea. Sleep Breath. 2003 Sep;7(3):119-30. doi: 10.1007/s11325-003-0119-3.
- Lee CH, Mo JH, Choi IJ, Lee HJ, Seo BS, Kim DY, Yun PY, Yoon IY, Won Lee H, Kim JW. The mandibular advancement device and patient selection in the treatment of obstructive sleep apnea. Arch Otolaryngol Head Neck Surg. 2009 May;135(5):439-44. doi: 10.1001/archoto.2009.31.
- Petri N, Svanholt P, Solow B, Wildschiodtz G, Winkel P. Mandibular advancement appliance for obstructive sleep apnoea: results of a randomised placebo controlled trial using parallel group design. J Sleep Res. 2008 Jun;17(2):221-9. doi: 10.1111/j.1365-2869.2008.00645.x.
- Nerfeldt P, Friberg D. Effectiveness of Oral Appliances in Obstructive Sleep Apnea with Respiratory Arousals. J Clin Sleep Med. 2016 Aug 15;12(8):1159-65. doi: 10.5664/jcsm.6058.
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2015-KAEK-84
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.
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