Obstructive Sleep Apnea Patients Treated With Mandibular Advancement Device

Sleep Apnea, Obstructive Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05621577
• Other study ID #: sleep apnea orthodontics
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 5, 2023
• Est. completion date: August 1, 2023

Study information

• Verified date: February 2023
• Source: Hawler Medical University
• Contact: haval rasheed, Assist.lec
• Phone: +9647504473642
• Email: haval.rasheed[@]epu.edu.iq
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: August 1, 2023
• Est. primary completion date: July 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• MANDIBULAR ADVANCEMENT DEVICE
orthodontically treating obstructive sleep apnea

Locations

Country	Name	City	State
Iraq	Hawler medical university	Erbil

Sponsors (1)

Lead Sponsor	Collaborator
Hawler Medical University

Country where clinical trial is conducted

Iraq, 

References & Publications (9)

Bariani RCB, Bigliazzi R, Cappellette Junior M, Moreira G, Fujita RR. Effectiveness of functional orthodontic appliances in obstructive sleep apnea treatment in children: literature review. Braz J Otorhinolaryngol. 2022 Mar-Apr;88(2):263-278. doi: 10.1016 — View Citation

Bozzini MF, Di Francesco RC, Soster LA. Clinical and anatomical characteristics associated with obstructive sleep apnea severity in children. Clinics (Sao Paulo). 2022 Nov 1;77:100131. doi: 10.1016/j.clinsp.2022.100131. eCollection 2022. — View Citation

Damian A, Gozal D. Innovations in the Treatment of Pediatric Obstructive Sleep Apnea. Adv Exp Med Biol. 2022;1384:339-350. doi: 10.1007/978-3-031-06413-5_20. — View Citation

Gambino F, Zammuto MM, Virzi A, Conti G, Bonsignore MR. Treatment options in obstructive sleep apnea. Intern Emerg Med. 2022 Jun;17(4):971-978. doi: 10.1007/s11739-022-02983-1. Epub 2022 Apr 23. — View Citation

Ho ACH, Savoldi F, Wong RWK, Fung SC, Li SKY, Yang Y, Gu M. Prevalence and Risk Factors for Obstructive Sleep Apnea Syndrome Among Children and Adolescents with Cleft lip and Palate: A Survey Study in Hong Kong. Cleft Palate Craniofac J. 2021 Dec 23:10556656211068306. doi: 10.1177/10556656211068306. Online ahead of print. — View Citation

Keim RG, Graham JW, Palomo JM, Shoaf SC, Tanguay D. Obstructive sleep apnea treatment in orthodontic practices. J Clin Orthod. 2022 Jan;56(1):23-33. No abstract available. — View Citation

Keim RG. The orthodontist and obstructive sleep apnea. J Clin Orthod. 2022 Jan;56(1):8. No abstract available. — View Citation

Randerath W, Verbraecken J, de Raaff CAL, Hedner J, Herkenrath S, Hohenhorst W, Jakob T, Marrone O, Marklund M, McNicholas WT, Morgan RL, Pepin JL, Schiza S, Skoetz N, Smyth D, Steier J, Tonia T, Trzepizur W, van Mechelen PH, Wijkstra P. European Respiratory Society guideline on non-CPAP therapies for obstructive sleep apnoea. Eur Respir Rev. 2021 Nov 30;30(162):210200. doi: 10.1183/16000617.0200-2021. Print 2021 Dec 31. — View Citation

Triggs A, Roberson G, Chaudhry K, Subramani K. Screening for obstructive sleep apnea by orthodontists in the United States - A survey study. J Clin Exp Dent. 2022 Aug 1;14(8):e625-e632. doi: 10.4317/jced.59708. eCollection 2022 Aug. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	measuring polysomnography record changes pre and post using appliance	comparing polysomnography readings before and after using MAD to evaluate appliance efficacy	6 months
Secondary	dental side effects	digital dental models before and after treatment to evaluate side effects	6 months