Obstructive Sleep Apnea
Conditions
Keywords
Snoring, Obstructive sleep apnea, Mandibular advancement device, Pulse oximeter device, Smartphone sleep applications
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.
Interventions
DEVICENon-titratable-customized mandibular advancement device
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.
Sponsors
Bahadır EZMEK
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline Apnea-Hypopnea Index (AHI) at 6 months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Oxygen-desaturation index (ODI) | 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. |
| Snoring index (SI) | at baseline and in 6 months | SI was used to evaluate snoring events per hour during PSG |
| Simple pulse oximeter (SPO)/ODI | 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 |
| Smartphone sleep application (SSA)/snoring intensity score (SIS) | 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 |
| SSA/snoring percentage (SP) | 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. |
Outcome results
None listed