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CompletedNCT04711083Updated Feb 16, 2022

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

An observational study in Obstructive Sleep Apnea and Diabetes Mellitus, Type 2, sponsored by Ain Shams University. Completed at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-02-16.

Sponsored by Ain Shams University · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
107
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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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Conditions studied

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In context

Apnea

1,422 studies on the registry are indexed under Apnea; 159 are open to participants now.

This study's enrollment of 107 is close to the median of 106 across 386 observational studies indexed under Apnea.

Browse Apnea studies →

Lead sponsor

Ain Shams University is the lead sponsor of 1,876 studies on the registry; 423 are open to participants now.

Of its 32 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

All patients 18 years old or above, with type 2 diabetes.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Observational model
Case-only
Time perspective
Prospective
Enrollment
107 participants (actual)
Patient registry
No

Interventions

  • Diagnostic testovernight 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 .

    Also known as: polysomnography

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What researchers measure

Primary outcomes

  1. correlation between nocturnal oxygen desaturation and glycemic control

    measurements of blood glucose control and nocturnal oxygen level.

    Time frame: 1 year

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Study locations

1 site
  • Ain Shams University
    Cairo, 11341, Egypt
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References and documents

Individual participant data

Plan to share: Undecided — results of noxturnal oximetry, patients demographics.

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 16, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04711083
Lead sponsor
Ain Shams University
Responsible party
Amr Shoukri (Assistant Professor of pulmonary medicine, Ain Shams University) — Principal investigator
First posted
Jan 15, 2021
Start date
Apr 20, 2020
Primary completion
Oct 20, 2021
Completion
Oct 20, 2021
Last update
Feb 16, 2022

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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