NCT03300700

Brief Summary

Obstructive sleep apnea (OSA) can be described as a condition characterized by repetitive obstruction of the upper airway resulting in oxygen desaturation and awakening from sleep, loud snoring, and increased daytime sleepiness . Many studies have shown that a link exists between OSA and cardiovascular disease, chronic heart failure ischemia, hypertension, obesity, and impaired glucose tolerance . A number of factors are likely to play role in development of clinical OSA syndrome (OSAS) ranging from upper airway anatomy to central respiratory control mechanisms. The pathophysiology of OSA is unclear and complex. Several previous studies have explored pulmonary function in the OSAS patients Interestingly, OSAS has been found to be highly correlated with lower airway obstruction, although it is originally defined as an upper airway disease

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

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

August 29, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 3, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

October 3, 2017

Status Verified

September 1, 2017

Enrollment Period

11 months

First QC Date

August 29, 2017

Last Update Submit

September 28, 2017

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (1)

  • Ventilatory parameters of cardiopulmonary exercise test

    End tidal Pco2 and Po2 will be measured in patients with obstructive sleep apnea

    30 minutes

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The study will be conducted as prospective study including 50 patients either admitted at our chest department or presented at our out patient clinic and diagnosed as Obstructive sleep apnea according to clinical picture and sleep study.

You may qualify if:

  • Stable OSA patients

You may not qualify if:

  • Cardiovascular diseases .
  • Orthopedic or neurological conditions affecting the ability of exercise.
  • Patients with previous lung resection or malignancies.
  • Patients with liver cell failure, renal failure.
  • Muscloskeletal disease.
  • Other chronic chest disease eg, ILD.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University Hospital

Asyut, Assiut,Egypt,Assiut university, Egypt

Location

Related Publications (5)

  • McNamara SG, Grunstein RR, Sullivan CE. Obstructive sleep apnoea. Thorax. 1993 Jul;48(7):754-64. doi: 10.1136/thx.48.7.754. No abstract available.

    PMID: 8153927BACKGROUND

  • Parish JM, Somers VK. Obstructive sleep apnea and cardiovascular disease. Mayo Clin Proc. 2004 Aug;79(8):1036-46. doi: 10.4065/79.8.1036.

    PMID: 15301332BACKGROUND

  • Levinson PD, McGarvey ST, Carlisle CC, Eveloff SE, Herbert PN, Millman RP. Adiposity and cardiovascular risk factors in men with obstructive sleep apnea. Chest. 1993 May;103(5):1336-42. doi: 10.1378/chest.103.5.1336.

    PMID: 8486007BACKGROUND

  • Ozturk L, Metin G, Cuhadaroglu C, Utkusavas A, Tutluoglu B. FEF(25-75)/FVC measurements and extrathoracic airway obstruction in obstructive sleep apnea patients. Sleep Breath. 2005 Mar;9(1):33-8. doi: 10.1007/s11325-005-0006-1.

    PMID: 15785919BACKGROUND

  • Vgontzas AN, Bixler EO, Chrousos GP. Sleep apnea is a manifestation of the metabolic syndrome. Sleep Med Rev. 2005 Jun;9(3):211-24. doi: 10.1016/j.smrv.2005.01.006.

    PMID: 15893251BACKGROUND

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

  • Raafat T El-Sokkary, prof

    Assiut University

    STUDY DIRECTOR

Central Study Contacts

Asmaa G Nafady, residant

CONTACT

00201015826887asmaanafady5922@yahoo.com

Ahmed M Azoz, Dr

CONTACT

00201002163907Ahmed_80metwally@yahoo.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 29, 2017

First Posted

October 3, 2017

Study Start

October 1, 2017

Primary Completion

September 1, 2018

Study Completion

March 1, 2020

Last Updated

October 3, 2017

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)