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

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

Study Description

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.

Study Design

• 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

Groups and Cohorts

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

Outcome Measures

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.

Eligibility Criteria

• 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

Contacts and Locations

Locations

Egypt

Ain Shams University; Recruiting

Cairo, Egypt, 11341

Contact: AMR SHOUKRI 01006601870 amr_shoukri@hotmail.com

Sponsors and Collaborators

Ain Shams University

More Information

• 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
• 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.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

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