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Status unknownNCT04324671Updated Apr 14, 2020

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

An observational study in Snoring, sponsored by Assiut University. Status unknown. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-04-14.

Sponsored by Assiut University · Observational

The sponsor has not verified this record recently (last verified Apr 2020), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
40
Ages
18 Years to 80 Years
Sex
All
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Study summary

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
Read the 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.

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Conditions studied

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In context

Sleep Apnea, Obstructive

2,198 studies on the registry are indexed under Sleep Apnea, Obstructive; 470 are open to participants now.

This study's planned enrollment of 40 is below the median of 104 across 648 observational studies indexed under Sleep Apnea, Obstructive.

Browse Sleep Apnea, Obstructive studies →

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
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

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
40 participants (estimated)
Patient registry
No

Interventions

  • Devicenasofibroscopy

    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.

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What researchers measure

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

    Time frame: baseline

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Study locations

No study locations are listed for this record.

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References and documents

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. PubMed 10606999 ↗
  • 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. PubMed 28668820 ↗
  • 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. PubMed 23066376 ↗

Related links

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 14, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04324671
Lead sponsor
Assiut University
Responsible party
Basma Khairy Mohamed (director, Assiut University) — Principal investigator
First posted
Mar 27, 2020
Start date
Jul 1, 2020 (estimated)
Primary completion
Jul 1, 2021 (estimated)
Completion
Dec 1, 2021 (estimated)
Last update
Apr 14, 2020

Study contacts

basma khairy, resident dr
Contact
boseym2010@yahoo.com
01023481606
reham abdelwkeel, lecturer
Contact
01069984894

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.

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