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Correlation Between Nocturnal Oxygen Desaturation and Glycemic Control in Diabetic Patients With Obstructive Sleep Apnea

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ClinicalTrials.gov Identifier: NCT04711083
Recruitment Status : Recruiting
First Posted : January 15, 2021
Last Update Posted : January 19, 2021
Sponsor:
Information provided by (Responsible Party):
Amr Shoukri, Ain Shams University

Brief Summary:

Nocturnal reduction in blood oxygen is expected independently associated with the development of worsened glycemic control in individuals with type 2 diabetes mellitus.

The aim of the present study is to assess the correlation between nocturnal oxygen desaturation assessed by overnight pulse oximetry and glycemic control in diabetic patients with obstructive sleep apnea.


Condition or disease Intervention/treatment
Obstructive Sleep Apnea Diabetes Mellitus, Type 2 Diagnostic Test: overnight pulse oximetry

Detailed Description:

Introduction:

Obstructive sleep apnea syndrome (OSAS) is a prevalent illness showing a heterogeneous symptom presentation, which ranges from low clinical suspicion to evident limitations in the quality of life. The main reasons for this variability relate to its potential association with major concomitant diseases, which include diabetes and a variety of cardiovascular pathologies. (1).

Also, OSA is a known risk factor for many comorbid disorders, causing resistance to conventional treatments and increasing the risk of mortality, which multiplies health care expenditures and even though the distribution of comorbidities differs between men and women, their effect progressively increases with OSA severity (2,3) Occurrence of apneic events and Reduction in blood oxygen and elevations in blood carbon dioxide are sensed by chemoreceptors in the brain and carotid bodies, which trigger brief microarousals and result in sleep fragmentation (4).

Nocturnal reduction in blood oxygen has also been independently associated with the development of worsened glycemic control in individuals with type 2 diabetes (4).

Aim of the work:

to assess the correlation between nocturnal oxygen desaturation assessed by overnight pulse oximetry and glycemic control in diabetic patients with obstructive sleep apnea.

Material and Methods:

This study will be conducted on all patients referred for evaluation of sleep related breathing disorders. All Medical files were reviewed. Data collected included .full medical history, demographics, measurements of weight and height, body mass index in kg/m2, neck circumference (NC), Epworth Sleepiness Scale (ESS) scores, measurements of overnight pulse oximetryglyceminc control (measurement of glycated HB, fasting and 2h postprandial blood sugar)The diagnosis that was concluded after a polysomnography study.

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Correlation Between Nocturnal Oxygen Desaturation and Glycemic Control in Diabetic Patients With Obstructive Sleep Apnea
Actual Study Start Date : April 20, 2020
Estimated Primary Completion Date : March 20, 2021
Estimated Study Completion Date : April 20, 2021

Resource links provided by the National Library of Medicine



Intervention Details:
  • Diagnostic Test: overnight pulse oximetry
    Wrist worn Overnight oximetry was performed using portable Nonin 2500 (Nonin Medical Inc., USA) pulse oximeters. The test was explained to the subjects and their caregiver by experienced health-care staff from the sleep unit. The recording was done at home and started just before going to bed and ended on awakening; the recommended duration was a minimum of 5 h and a maximum of 7 h. The awake SpO2, mean SpO2. The data were analysed to calculate the overnight minimum SpO2, mean SpO2, dip frequency (defined as a fall in SpO2 of > 4%), the percentage of oximetry sleep time spent with a SpO2 of < 90%, and the total oximetry time. Recordings were classified as "normal" (< 4.9 desaturation events an hour), "equivocal" (5 to 14.9 desaturation events an hour), or "abnormal" (> 15 desaturation events an hour) according to the severity and pattern of nocturnal desaturation observed .
    Other Name: polysomnography


Primary Outcome Measures :
  1. correlation between nocturnal oxygen desaturation and glycemic control [ Time Frame: 1 year ]
    measurements of blood glucose control and nocturnal oxygen level.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
All patients 18 years old or above, with type 2 diabetes.
Criteria

Inclusion Criteria:

  • All patient swith type 2 diabetes, referred for evaluation of sleep related breathing disorder

Exclusion Criteria:

  • Patients less than 18 years old and Patients receiving treatment for sleep related breathing disorders were excluded

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04711083


Locations
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Egypt
Ain Shams University Recruiting
Cairo, Egypt, 11341
Contact: AMR SHOUKRI    01006601870    amr_shoukri@hotmail.com   
Sponsors and Collaborators
Ain Shams University
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Responsible Party: Amr Shoukri, Assistant Professor of pulmonary medicine, Ain Shams University
ClinicalTrials.gov Identifier: NCT04711083    
Other Study ID Numbers: OPO10-18
First Posted: January 15, 2021    Key Record Dates
Last Update Posted: January 19, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: results of noxturnal oximetry, patients demographics.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Diabetes Mellitus, Type 2
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases