Obstructive Sleep Apnea Patients Treated With Mandibular... | NCT05621577

Studies
Obstructive Sleep Apnea Patients Treated With Mandibular Advancement Device

NCT05621577

Sponsor

Hawler Medical University

Status

Unknown status

Last Update Posted

Feb 8, 2023Actual

Enrollment

20Estimated

Phase

Not Applicable

Conditions

Sleep Apnea, Obstructive

Interventions

MANDIBULAR ADVANCEMENT DEVICE

Countries

Iraq

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 5, 2023Estimated

Primary Completion Date

Jul 1, 2023Estimated

Completion Date

Aug 1, 2023Estimated

First Submitted Date

Nov 7, 2022

First Submission Date that Met QC Criteria

Nov 14, 2022

First Posted Date

Nov 18, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 3, 2023

Last Update Posted Date

Feb 8, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Haval Jalal Rasheed, assistant lecturer, Hawler Medical UniversityPrincipal Investigator

Lead Sponsor

Hawler Medical UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
mandibular advancing device	Other	using mandibular advancement device for treatment of obstructive sleep apnea	Device: MANDIBULAR ADVANCEMENT DEVICE

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MANDIBULAR ADVANCEMENT DEVICE	Device	orthodontically treating obstructive sleep apnea	mandibular advancing device

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
dental side effects	digital dental models before and after treatment to evaluate side effects	6 months

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
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

Overall Officials

Name	Affiliation	Role
Zana Omer, Assist.Prof	Hawler Medical University	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hawler medical university		Erbil		44001	Iraq

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
34853097	Background	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.
35704888

ID	Term
D012891	Sleep Apnea Syndromes
D001049	Apnea
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases

ID	Term
D009989	Orthotic Devices
D009983	Orthopedic Equipment
D013523	Surgical Equipment
D004864	Equipment and Supplies