Clinical trial NCT04427111: Therapeutic Efficiency of Mandibular Advancement Device Using Smartphone Sleep Applications and Pulse Oximeter
Official title: Therapeutic Efficiency Analyses of Mandibular Advancement Devices on Obstructive Sleep Apnea Using Polysomnography, Smartphone Sleep Applications, and Simple Pulse Oximeter
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obstructive Sleep Apnea
Keywords: Snoring
Obstructive sleep apnea
Mandibular advancement device
Pulse oximeter device
Smartphone sleep applications
Lead sponsor: Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
Sponsor class: OTHER
First posted: 2020-06-11
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change from Baseline Apnea-Hypopnea Index (AHI) at 6 months
timeFrame: at baseline and in 6 months
Secondary outcomes:
measure: Oxygen-desaturation index (ODI)
timeFrame: at baseline and in 6 months
measure: Snoring index (SI)
timeFrame: at baseline and in 6 months
measure: Simple pulse oximeter (SPO)/ODI
timeFrame: at baseline and 1, 4, 12, and 24 week of MAD treatment
measure: Smartphone sleep application (SSA)/snoring intensity score (SIS)
timeFrame: at baseline and 1, 4, 12, and 24 week of MAD treatment
measure: SSA/snoring percentage (SP)
timeFrame: at baseline and 1, 4, 12, and 24 week of MAD treatment
Other outcomes:
Locations:
Study officials:
affiliation: Technology of Dental Prosthodontics, Kapadokya University, Turkey
name: Bulent Piskin, Prof.
role: STUDY_CHAIR
References:
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