SnoringNCT04324671
Upper Airway Obstruction in Non-obese Patients With Snoring and Obstructive Sleep Apnea
An observational study of Snoring, run by Assiut University.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Snoring
- What is being tested?
- nasofibroscopy
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2020to 1 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Adult, Older adult
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
Who may be able to join
- older than 18 years
- patients complaining of snoring and obstructive sleep panea
Who cannot join
- chronic pulmonary disease ( COPD, Asthma ,IPF)
- Pregnancy
- sever cardiovascular disease ( unstable angina , sever arrhythmia , MI)
- chronic renal failure (CRF)
- neurological disorders
Trial locations and contacts
No sites are listed yet.
reham abdelwkeel, lecturer contact
About this study
Official title: a Study of the Pattern of Upper Airway Obstruction in Non-obese Patients With Snoring and Obstructive Sleep Apnea
This study aims at :-
- detecting the prevelance of snoring and OSA in non-obese patients
- 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.
- Conditions
- Snoring
- Being tested
- nasofibroscopy
- Medical subject headings
- Snoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nasofibroscopyDevice
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2020
- Study start1 Jul 2020 (estimated)
- Primary completion1 Jul 2021 (estimated)
- Study completion1 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for SnoringStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Basma Khairy Mohamed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04324671
- Sponsor's protocol ID
- snoring in non-obese
- Status last verified
- Apr 2020
- First submitted
- 25 Mar 2020
- Last updated
- 14 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 10606999Tung 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 28668820Berry 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
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- a Study of the Pattern of Upper Airway Obstruction in Non-obese Patients With Snoring and Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT04324671
- Acronym / sponsor ID
- snoring in non-obese
- Conditions
- Snoring
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jul 2020 (estimated)
- Primary completion
- 1 Jul 2021 (estimated)
- Study completion
- 1 Dec 2021 (estimated)
- First posted
- 27 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims at :-
- detecting the prevelance of snoring and OSA in non-obese patients
- identify their diagnostic profile in order to provide proper management
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- older than 18 years
- patients complaining of snoring and obstructive sleep panea
Key exclusion criteria (5 listed)
- chronic pulmonary disease ( COPD, Asthma ,IPF)
- Pregnancy
- sever cardiovascular disease ( unstable angina , sever arrhythmia , MI)
- chronic renal failure (CRF)
- neurological disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nasofibroscopyFlexible 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. | Device | – |
Primary outcome
compare snoring and obstructive sleep apnea between obese and non obese
Time frame: baseline
by analysing data of muller's manauver and sleep endoscopy between obese and nonobese
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2020.
- Background: PubMed 10606999Armstrong 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.
- Background: PubMed 28668820Tung 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.
- Background: PubMed 23066376Berry 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.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
reham abdelwkeel, lecturer contact
Questions about this trial
What is this clinical trial studying?
An observational study of Snoring, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact basma khairy, resident dr (01023481606, boseym2010@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
compare snoring and obstructive sleep apnea between obese and non obese (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04324671, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2020.