Correlation Between Nocturnal Oxygen Desaturation and Glycemic Control in Diabetic Patients With Obstructive Sleep Apnea
1 other identifier
observational
107
1 country
1
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.
Trial Health
Trial Health Score
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participants targeted
Target at P50-P75 for all trials
Started Apr 2020
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 20, 2020
CompletedFirst Submitted
Initial submission to the registry
January 13, 2021
CompletedFirst Posted
Study publicly available on registry
January 15, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 20, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 20, 2021
CompletedFebruary 16, 2022
February 1, 2022
1.5 years
January 13, 2021
February 15, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
correlation between nocturnal oxygen desaturation and glycemic control
measurements of blood glucose control and nocturnal oxygen level.
1 year
Interventions
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 .
Eligibility Criteria
All patients 18 years old or above, with type 2 diabetes.
You may qualify if:
- All patient swith type 2 diabetes, referred for evaluation of sleep related breathing disorder
You may not qualify if:
- Patients less than 18 years old and Patients receiving treatment for sleep related breathing disorders were excluded
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ain Shams University
Cairo, 11341, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of pulmonary medicine
Study Record Dates
First Submitted
January 13, 2021
First Posted
January 15, 2021
Study Start
April 20, 2020
Primary Completion
October 20, 2021
Study Completion
October 20, 2021
Last Updated
February 16, 2022
Record last verified: 2022-02