NCT04324671

Brief Summary

This study aims at :-

  1. 1.detecting the prevelance of snoring and OSA in non-obese patients
  2. 2.identify their diagnostic profile in order to provide proper management

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2020

Status
unknown

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

March 25, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 27, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

July 1, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

April 14, 2020

Status Verified

April 1, 2020

Enrollment Period

1 year

First QC Date

March 25, 2020

Last Update Submit

April 12, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • compare snoring and obstructive sleep apnea between obese and non obese

    by analysing data of muller's manauver and sleep endoscopy between obese and nonobese

    baseline

Interventions

Flexible videorhinolaryngoscope, PAL 11101VP\*, 4.2 mm diameter. Using a computerized system including: Light source: Explor ENT (HAL250). The software allowed audio, video recording and retrieval of recorded material.

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

all patients refaired to outpatient clinic of Phoniatric Unit, Assiut University Hospital in duration of 1 year with history of snoring and history suggestive of obstructive sleep apnea will be included in this study

You may qualify if:

  • older than 18 years
  • patients complaining of snoring and obstructive sleep panea

You may not qualify if:

  • chronic pulmonary disease ( COPD, Asthma ,IPF)
  • Pregnancy
  • sever cardiovascular disease ( unstable angina , sever arrhythmia , MI)
  • chronic renal failure (CRF)
  • neurological disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Armstrong MW, Wallace CL, Marais J. The effect of surgery upon the quality of life in snoring patients and their partners: a between-subjects case-controlled trial. Clin Otolaryngol Allied Sci. 1999 Dec;24(6):510-22. doi: 10.1046/j.1365-2273.1999.00307.x.

    PMID: 10606999BACKGROUND
  • Tung P, Levitzky YS, Wang R, Weng J, Quan SF, Gottlieb DJ, Rueschman M, Punjabi NM, Mehra R, Bertisch S, Benjamin EJ, Redline S. Obstructive and Central Sleep Apnea and the Risk of Incident Atrial Fibrillation in a Community Cohort of Men and Women. J Am Heart Assoc. 2017 Jul 1;6(7):e004500. doi: 10.1161/JAHA.116.004500.

    PMID: 28668820BACKGROUND
  • Berry RB, Budhiraja R, Gottlieb DJ, Gozal D, Iber C, Kapur VK, Marcus CL, Mehra R, Parthasarathy S, Quan SF, Redline S, Strohl KP, Davidson Ward SL, Tangredi MM; American Academy of Sleep Medicine. Rules for scoring respiratory events in sleep: update of the 2007 AASM Manual for the Scoring of Sleep and Associated Events. Deliberations of the Sleep Apnea Definitions Task Force of the American Academy of Sleep Medicine. J Clin Sleep Med. 2012 Oct 15;8(5):597-619. doi: 10.5664/jcsm.2172.

    PMID: 23066376BACKGROUND

Related Links

MeSH Terms

Conditions

Snoring

Condition Hierarchy (Ancestors)

Respiratory SoundsSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

basma khairy, resident dr

CONTACT

reham abdelwkeel, lecturer

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
director

Study Record Dates

First Submitted

March 25, 2020

First Posted

March 27, 2020

Study Start

July 1, 2020

Primary Completion

July 1, 2021

Study Completion

December 1, 2021

Last Updated

April 14, 2020

Record last verified: 2020-04