Obstructive Sleep Apnea Patients Treated With Mandibular Advancement Device

Not Applicable

Not yet recruiting

• Conditions: Sleep Apnea, Obstructive
• Interventions: Device: MANDIBULAR ADVANCEMENT DEVICE

• Registration Number: NCT05621577
• Lead Sponsor: Hawler Medical University

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.

Study Timeline

• Study First Submitted: 2022-11-07
• Study First Submitted QC: 2022-11-14
• Study First Posted: 2022-11-18
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-03
• Study Start: 2023-02-05
• Last Update Posted: 2023-02-08
• Primary Completion: 2023-07-01
• Study Completion: 2023-08-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
mandibular advancing device	MANDIBULAR ADVANCEMENT DEVICE	using mandibular advancement device for treatment of obstructive sleep apnea

Primary Outcome Measures

Name	Time	Method
measuring polysomnography record changes pre and post using appliance	6 months	comparing polysomnography readings before and after using MAD to evaluate appliance efficacy

Secondary Outcome Measures

Name	Time	Method
dental side effects	6 months	digital dental models before and after treatment to evaluate side effects

Trial Locations

Locations (1)

Hawler medical university; 🇮🇶 Erbil, Iraq