Obstructive Sleep Apnea Patients Treated With Mandibular Advancement Device
Primary Purpose
Sleep Apnea, Obstructive
Status
Not yet recruiting
Phase
Not Applicable
Locations
Iraq
Study Type
Interventional
Intervention
MANDIBULAR ADVANCEMENT DEVICE
Sponsored by
About this trial
This is an interventional treatment trial for Sleep Apnea, Obstructive focused on measuring orthodontic
Eligibility Criteria
Inclusion Criteria: sample will be taken from Kurdish population in Erbil city. Obstructive sleep apnea, apnea-hypopnea index of <30 with excessive daytime sleepiness Exclusion Criteria: 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.
Sites / Locations
- Hawler medical university
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
mandibular advancing device
Arm Description
using mandibular advancement device for treatment of obstructive sleep apnea
Outcomes
Primary Outcome Measures
measuring polysomnography record changes pre and post using appliance
comparing polysomnography readings before and after using MAD to evaluate appliance efficacy
Secondary Outcome Measures
dental side effects
digital dental models before and after treatment to evaluate side effects
Full Information
NCT ID
NCT05621577
First Posted
November 7, 2022
Last Updated
February 3, 2023
Sponsor
Hawler Medical University
1. Study Identification
Unique Protocol Identification Number
NCT05621577
Brief Title
Obstructive Sleep Apnea Patients Treated With Mandibular Advancement Device
Official Title
Socio-Demographic - Dental & Respiratory Changes of Obstructive Sleep Apnea (OSA) Patients Treated With Mandibular Advancement Device (MAD) of Samples in Erbil City
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
February 5, 2023 (Anticipated)
Primary Completion Date
July 1, 2023 (Anticipated)
Study Completion Date
August 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hawler Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea, Obstructive
Keywords
orthodontic
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
mandibular advancing device
Arm Type
Other
Arm Description
using mandibular advancement device for treatment of obstructive sleep apnea
Intervention Type
Device
Intervention Name(s)
MANDIBULAR ADVANCEMENT DEVICE
Intervention Description
orthodontically treating obstructive sleep apnea
Primary Outcome Measure Information:
Title
measuring polysomnography record changes pre and post using appliance
Description
comparing polysomnography readings before and after using MAD to evaluate appliance efficacy
Time Frame
6 months
Secondary Outcome Measure Information:
Title
dental side effects
Description
digital dental models before and after treatment to evaluate side effects
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
sample will be taken from Kurdish population in Erbil city.
Obstructive sleep apnea, apnea-hypopnea index of <30 with excessive daytime sleepiness
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
haval rasheed, Assist.lec
Phone
+9647504473642
Email
haval.rasheed@epu.edu.iq
First Name & Middle Initial & Last Name or Official Title & Degree
Zana Omer, Assist.Prof.
Phone
+964-750-448-12-47
Email
Zana.qadir@hmu.edu.krd
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zana Omer, Assist.Prof
Organizational Affiliation
Hawler Medical University
Official's Role
Study Director
Facility Information:
Facility Name
Hawler medical university
City
Erbil
ZIP/Postal Code
44001
Country
Iraq
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34853097
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.
Results Reference
background
PubMed Identifier
35704888
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.
Results Reference
background
PubMed Identifier
35704890
Citation
Keim RG. The orthodontist and obstructive sleep apnea. J Clin Orthod. 2022 Jan;56(1):8. No abstract available.
Results Reference
background
PubMed Identifier
35460431
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.
Results Reference
background
PubMed Identifier
36217094
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.
Results Reference
background
PubMed Identifier
34939456
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. 2023 Apr;60(4):421-429. doi: 10.1177/10556656211068306. Epub 2021 Dec 23.
Results Reference
background
PubMed Identifier
36046169
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.
Results Reference
background
PubMed Identifier
36334493
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.
Results Reference
background
PubMed Identifier
33757756
Citation
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.
Results Reference
result
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Obstructive Sleep Apnea Patients Treated With Mandibular Advancement Device
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