Obstructive Sleep Apnea Patients Treated With Mandibular Advancement Device

NCT ID: NCT05621577

Last Updated: 2023-02-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-05

Study Completion Date

2023-08-01

Brief Summary

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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

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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.

Conditions

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Sleep Apnea, Obstructive

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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mandibular advancing device

using mandibular advancement device for treatment of obstructive sleep apnea

Group Type OTHER

MANDIBULAR ADVANCEMENT DEVICE

Intervention Type DEVICE

orthodontically treating obstructive sleep apnea

Interventions

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MANDIBULAR ADVANCEMENT DEVICE

orthodontically treating obstructive sleep apnea

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

25 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hawler Medical University

OTHER

Sponsor Role lead

Responsible Party

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Haval Jalal Rasheed

assistant lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zana Omer, Assist.Prof

Role: STUDY_DIRECTOR

Hawler Medical University

Locations

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Hawler medical university

Erbil, , Iraq

Site Status

Countries

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Iraq

Central Contacts

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haval rasheed, Assist.lec

Role: CONTACT

+9647504473642

Zana Omer, Assist.Prof.

Role: CONTACT

+964-750-448-12-47

References

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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.

Reference Type BACKGROUND
PMID: 34853097 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35704888 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 35704890 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35460431 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36217094 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34939456 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36046169 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36334493 (View on PubMed)

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.

Reference Type RESULT
PMID: 33757756 (View on PubMed)

Other Identifiers

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sleep apnea orthodontics

Identifier Type: -

Identifier Source: org_study_id

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