Obstructive Sleep Apnea Patients Treated With Mandibular Advancement Device

NCT05621577 | Unknown

• 1 other identifier: sleep apnea orthodontics
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

Sleep Apnea, Obstructive

Keywords

orthodontic

Outcome Measures

Primary Outcomes (1)

• measuring polysomnography record changes pre and post using appliance

  comparing polysomnography readings before and after using MAD to evaluate appliance efficacy

  6 months

Secondary Outcomes (1)

• dental side effects

  6 months

Study Arms (1)

mandibular advancing device

OTHER

using mandibular advancement device for treatment of obstructive sleep apnea

Device: MANDIBULAR ADVANCEMENT DEVICE

Interventions

MANDIBULAR ADVANCEMENT DEVICE DEVICE

orthodontically treating obstructive sleep apnea

mandibular advancing device

Eligibility Criteria

• Age: 25 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hawler Medical University: lead

Study Sites (1)

Hawler medical university

Erbil, 44001, Iraq

Location

Related Publications (9)

• 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.

  PMID: 34853097 BACKGROUND

• 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.

  PMID: 35704888 BACKGROUND

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

  PMID: 35704890 BACKGROUND

• 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.

  PMID: 35460431 BACKGROUND

• 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.

  PMID: 36217094 BACKGROUND

• 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. 2023 Apr;60(4):421-429. doi: 10.1177/10556656211068306. Epub 2021 Dec 23.

  PMID: 34939456 BACKGROUND

• 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.

  PMID: 36046169 BACKGROUND

• 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.

  PMID: 36334493 BACKGROUND

• 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/j.bjorl.2021.02.010. Epub 2021 Mar 14.

  PMID: 33757756 RESULT

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Occlusal Splints

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Orthotic Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies

Study Officials

• Zana Omer, Assist.Prof

  Hawler Medical University

  STUDY DIRECTOR

Central Study Contacts

haval rasheed, Assist.lec

CONTACT

+9647504473642; haval.rasheed@epu.edu.iq

Zana Omer, Assist.Prof.

CONTACT

+964-750-448-12-47; Zana.qadir@hmu.edu.krd

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecturer

Study Record Dates

• First Submitted: November 7, 2022
• First Posted: November 18, 2022
• Study Start: February 5, 2023
• Primary Completion: July 1, 2023
• Study Completion: August 1, 2023
• Last Updated: February 8, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)