Upper Airway Obstruction in Non-obese Patients With Snoring and Obstructive Sleep Apnea

a Study of the Pattern of Upper Airway Obstruction in Non-obese Patients With Snoring and Obstructive Sleep Apnea

This study aims at :-

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

Study Overview

• Status: Unknown
• Conditions: Snoring
• Intervention / Treatment: Device: nasofibroscopy

Detailed Description

Snoring is the vibration of respiratory structures and the resulting sound due to obstructed air movement during breathing while sleeping.

Snoring during sleep may be a sign, or first alarm, of obstructive sleep apnea (OSA).

Snoring can cause significant psychological and social problems to sufferers. Multiple studies reveal a positive correlation between loud snoring and risk of heart attack and stroke.

Obstructive sleep apnea (OSA) is the commonest type of sleep apnea and is characterized by inturpted snoring, repeated attacks of complete or partial pharyngeal closure during sleep despite the effort to breath resulting in nocturnal hypoxemia, frequent arousals during sleep, and excessive daytime sleepiness (EDS).

Obstructive Sleep Apnea is differentiated from Central Sleep Apnea (CSA) which is characterized by changes in the respiratory cycle during sleep but without the effort to breath during the apnea.

the episodes of decreased breathing are called "hypopnea " and it's definition requires a < 30% drop in flow for 10 seconds or longer associated with < 3% oxygen desaturation , the episodes of breathing cessations are called "apneas" and defined as a< 90% drop in flow for 10 seconds or longer and associated with < 3% oxygen desaturation or an arousal It is a serious and potentially life threatening disease that is far more common than generally expected. Several risk factors, including obesity, male sex, age, and heritable factors, as well as the supine decubitus position during sleep. have been associated with an increased prevalence of obstructive sleep apnea in the general population.

It has become a major health issue all over the world affecting quality of life with an increasing prevalence and associated with high comorbidities such as diabetes mellitus, hypertension, cardiovascular disease, dyslipidemia, malignancies, and overall mortality. Results of different studies indicate that approximately 60-70% of patients with OSA are obese.

Snoring and witnessed apnea are more frequent among men but insomnia for example is more frequent among women. The OSA frequency increase with age for the women. The mortality is higher for women The data regarding association of OSA among nonobese patients is rare and needs great effort as fewer studies have reported magnitude of association.

• Study Type: Observational
• Enrollment (Anticipated): 40

Contacts and Locations

• Study Contact: Name: basma khairy, resident dr; Phone Number: 01023481606; Email: boseym2010@yahoo.com
• Study Contact Backup: Name: reham abdelwkeel, lecturer; Phone Number: 01069984894

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability 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

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Assiut University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2020
• Primary Completion (Anticipated): July 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: March 25, 2020
• First Submitted That Met QC Criteria: March 25, 2020
• First Posted (Actual): March 27, 2020

Study Record Updates

• Last Update Posted (Actual): April 14, 2020
• Last Update Submitted That Met QC Criteria: April 12, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Respiratory Sounds; Respiratory Insufficiency; Sleep Apnea, Obstructive; Snoring; Airway Obstruction
• Other Study ID Numbers: snoring in non-obese

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No