NCT04572503

Brief Summary

The aim of this study is to evaluate the effectiveness of barbed suture modification of anterior palatoplasty in the treatment of patients with retropalatal mild to moderate obstructive sleep apnea syndrome (OSAS).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 26, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 1, 2020

Completed
6 days until next milestone

Study Start

First participant enrolled

October 7, 2020

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

August 28, 2024

Status Verified

August 1, 2024

Enrollment Period

5.2 years

First QC Date

September 26, 2020

Last Update Submit

August 27, 2024

Conditions

Obstructive Sleep Apnea

Keywords

Obstructive Sleep ApneaBarbed sutureAnterior palatoplasty

Outcome Measures

Primary Outcomes (1)

  • Apnea Hypopnea index

    one-night polysomnographic study at sleep lab. The apnea-hypopnea index denotes the total numbers of apnea plus hypopnea events divided by total sleep time in hours (0-5/ hr sleep = mild, 6-15/hr sleep = moderate, more than 15/hr sleep = severe)

    6 months

Study Arms (1)

Modified Anterior Palatoplasty

EXPERIMENTAL

Barbed Suture Modified Anterior Palatoplasty In Management of Mild and Moderate Obstructive Sleep Apnea Syndromea using single resorbable polydioxanone barbed bidirectional size 0 monofilament suture

Procedure: Barbed Suture Modified Anterior Palatoplasty

Interventions

Barbed Suture Modified Anterior PalatoplastyPROCEDURE

Barbed Suture Modified Anterior Palatoplasty using single resorbable polydioxanone barbed bidirectional size 0 monofilament suture

Modified Anterior Palatoplasty

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with mild to moderate obstructive sleep apnea syndrome.
  • Patients diagnosed with mild (AHI 5 to15) and moderate (AHI 16 to 30) OSAS with only retropalatal collapses
  • Patients who are noncompliant with Continuous positive airway pressure (CPAP).

You may not qualify if:

  • Patients diagnosed with sever OSAS (AHI more than 30)
  • The main site of obstruction at retrolingual level or multilevel obstruction.
  • Contraindication of surgery (e.g. cardiovascular problems and bleeding tendency).
  • Patients with significant craniofacial anomalies affecting airway.
  • Patients with BMI\>40 kg/m2.
  • Patients unfit for general anesthesia.
  • History of previous velopharyngeal or lingual surgeries.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Benha University Hospital, Faculty of Medicine

Banhā, Qalyubia Governorate, 13512, Egypt

RECRUITING

Related Publications (2)

  • Pianta L, Bertazzoni G, Morello R, Perotti P, Nicolai P. Barbed expansion sphincter pharyngoplasty for the treatment of oropharyngeal collapse in obstructive sleep apnoea syndrome: A retrospective study on 17 patients. Clin Otolaryngol. 2018 Apr;43(2):696-700. doi: 10.1111/coa.13008. Epub 2017 Nov 6. No abstract available.

    PMID: 29045003BACKGROUND

  • Salamanca F, Costantini F, Mantovani M, Bianchi A, Amaina T, Colombo E, Zibordi F. Barbed anterior pharyngoplasty: an evolution of anterior palatoplasty. Acta Otorhinolaryngol Ital. 2014 Dec;34(6):434-8.

    PMID: 25762837BACKGROUND

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Abdelrahman A Abdelalim, MD

    Benha University

    PRINCIPAL INVESTIGATOR

  • Mohamed A Elsayed, MD

    Benha University

    STUDY CHAIR

  • Hesham A Abdelsamea, MD

    Benha University

    STUDY CHAIR

  • Ahmed Y Abdelsalam, Resident

    Al-Agouza specialized hospital

    STUDY CHAIR

Central Study Contacts

Abdelrahman A Abdelalim, MD

CONTACT

0201069372609aborazan2009@gmail.com

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
MD Lecturer

Study Record Dates

First Submitted

September 26, 2020

First Posted

October 1, 2020

Study Start

October 7, 2020

Primary Completion

December 1, 2025

Study Completion

March 1, 2026

Last Updated

August 28, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)