Clinical trial NCT05621577: Obstructive Sleep Apnea Patients Treated With Mandibular Advancement Device
Official title: Socio-Demographic - Dental & Respiratory Changes of Obstructive Sleep Apnea (OSA) Patients Treated With Mandibular Advancement Device (MAD) of Samples in Erbil City
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sleep Apnea, Obstructive
Keywords: orthodontic
Lead sponsor: Hawler Medical University
Sponsor class: OTHER
First posted: 2022-11-18
Enrollment: 20
Sex: ALL
Minimum age (years): 25
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. sample will be taken from Kurdish population in Erbil city.
2. Obstructive sleep apnea, apnea-hypopnea index of \<30 with excessive daytime sleepiness

Exclusion Criteria:

1. People with problems in nasal part of airway.
2. People with cleft lip and palate
3. Patient who did tonsillectomy and / or other pharyngeal operations.
4. People who take any kind of sleep medication.
5. Temporomandibular Disorders.
6. People with periodontal disease.
7. Less than 8 teeth/ arch.

Primary outcomes:
measure: measuring polysomnography record changes pre and post using appliance
timeFrame: 6 months
Secondary outcomes:
measure: dental side effects
timeFrame: 6 months
Other outcomes:
Locations:
city: Erbil
country: Iraq
facility: Hawler medical university
Study officials:
affiliation: Hawler Medical University
name: Zana Omer, Assist.Prof
role: STUDY_DIRECTOR
References:
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