An interventional study of MANDIBULAR ADVANCEMENT DEVICE in Sleep Apnea, Obstructive, sponsored by Hawler Medical University. Status unknown at 1 site in Iraq. Open to participants aged 25 Years to 50 Years. Per ClinicalTrials.gov, last updated 2023-02-08.
Sponsored by Hawler Medical University · Not applicable, Interventional, and Treatment
The purpose of this study is to evaluate efficacy of mandibular advancement device (MAD). on treating obstructive sleep apneas, symptoms, Apnea/Hypopnea Index (QHI) and the Respiratory Arousal Index (AHI/REI) and peripheral capillary oxygen saturation (SpO2) Range, PULSE in patients with mild to moderate obstructive sleep apnea/hypopnea syndrome, and evaluating potential dental side effects
The primary oral appliance (OA) used in obstructive sleep apnea (OSA) treatment is the mandibular advancement device (MAD). MADs may be either an over-the-counter stock device or customized for individual patients. MADs come in various designs and materials, but most comprise upper and lower splints mounted over the dentition as either a 1-piece monoblock or a 2-piece biblock Connectors or blocks relate the upper and lower splints in a biblock to protrude the mandible in a forward position during sleep.
Although the efficacy of oral appliances has been proved, the relationship to the nature of airway enlargement in patients with OSA has not yet been clearly demonstrated.
The aim of this study is therefore to evaluate the efficacy mandibular repositioning appliance reduces sleep apneas symptoms with mild to moderate obstructive sleep apnea . Secondary outcomes include the dental side effects of such appliance. At baseline and after 4 month's treatment, This study will be conducted to estimate frequency of OSA on population sample from Erbil study, in addition trying to evaluate the efficiency of MAD on some patients who are diagnosed with OSA.
2,263 studies on the registry are indexed under Sleep Apnea, Obstructive; 465 are open to participants now.
This study's planned enrollment of 20 is below the median of 53 across 1,490 interventional studies indexed under Sleep Apnea, Obstructive.
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Exclusion Criteria:
using mandibular advancement device for treatment of obstructive sleep apnea
Device: MANDIBULAR ADVANCEMENT DEVICE
orthodontically treating obstructive sleep apnea
measuring polysomnography record changes pre and post using appliance
comparing polysomnography readings before and after using MAD to evaluate appliance efficacy
Time frame: 6 months
dental side effects
digital dental models before and after treatment to evaluate side effects
Time frame: 6 months
Plan to share: No
This study is status unknown, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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Hawler Medical University