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
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
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. |
Country | Name | City | State |
---|---|---|---|
Iraq | Hawler medical university | Erbil |
Lead Sponsor | Collaborator |
---|---|
Hawler Medical University |
Iraq,
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
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 |
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