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Obstructive Sleep Apnea Patients Treated With Mandibular Advancement Device

Socio-Demographic - Dental & Respiratory Changes of Obstructive Sleep Apnea (OSA) Patients Treated With Mandibular Advancement Device (MAD) of Samples in Erbil City

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05621577
Enrollment
20
Registered
2022-11-18
Start date
2023-02-05
Completion date
2023-08-01
Last updated
2023-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep Apnea, Obstructive

Keywords

orthodontic

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.

Interventions

DEVICEMANDIBULAR ADVANCEMENT DEVICE

orthodontically treating obstructive sleep apnea

Sponsors

Hawler Medical University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
25 Years to 50 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
measuring polysomnography record changes pre and post using appliance6 monthscomparing polysomnography readings before and after using MAD to evaluate appliance efficacy

Secondary

MeasureTime frameDescription
dental side effects6 monthsdigital dental models before and after treatment to evaluate side effects

Countries

Iraq

Contacts

Primary Contacthaval rasheed, Assist.lec
haval.rasheed@epu.edu.iq+9647504473642
Backup ContactZana Omer, Assist.Prof.
Zana.qadir@hmu.edu.krd+964-750-448-12-47

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026