Obstructive Sleep ApneaNCT04711083
Correlation Between Nocturnal Oxygen Desaturation and Glycemic Control in Diabetic Patients With Obstructive Sleep Apnea
An observational study of Obstructive Sleep Apnea and Diabetes Mellitus, Type 2, run by Ain Shams University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea, Diabetes Mellitus, Type 2
- What is being tested?
- overnight pulse oximetry
- How many people
- 107 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Apr 2020to 20 Oct 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: All patients 18 years old or above, with type 2 diabetes.
Who may be able to join
- All patient swith type 2 diabetes, referred for evaluation of sleep related breathing disorder
Who cannot join
- Patients less than 18 years old and Patients receiving treatment for sleep related breathing disorders were excluded
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Obstructive Sleep Apnea, Diabetes Mellitus, Type 2
- Being tested
- overnight pulse oximetry
- Medical subject headings
- Sleep Apnea, Obstructive, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
overnight pulse oximetryDiagnostic test
Also called polysomnography
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 .
What is being measured
The primary outcome is the main question the study is designed to answer.
correlation between nocturnal oxygen desaturation and glycemic control
measurements of blood glucose control and nocturnal oxygen level.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2021
- Study start20 Apr 2020
- Primary completion20 Oct 2021
- Study completion20 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr Shoukri, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04711083
- Sponsor's protocol ID
- OPO10-18
- Status last verified
- Feb 2022
- First submitted
- 13 Jan 2021
- Last updated
- 16 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: results of noxturnal oximetry, patients demographics.
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Nocturnal Oxygen Desaturation and Glycemic Control in Diabetic Patients With Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT04711083
- Acronym / sponsor ID
- OPO10-18
- Conditions
- Obstructive Sleep Apnea, Diabetes Mellitus, Type 2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 20 Apr 2020 (actual)
- Primary completion
- 20 Oct 2021 (actual)
- Study completion
- 20 Oct 2021 (actual)
- First posted
- 15 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All patients 18 years old or above, with type 2 diabetes.
Key inclusion criteria (1 listed)
- All patient swith type 2 diabetes, referred for evaluation of sleep related breathing disorder
Key exclusion criteria (1 listed)
- Patients less than 18 years old and Patients receiving treatment for sleep related breathing disorders were excluded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| overnight pulse oximetryAlso: polysomnographyWrist 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 . | Diagnostic test | – |
Primary outcome
correlation between nocturnal oxygen desaturation and glycemic control
Time frame: 1 year
measurements of blood glucose control and nocturnal oxygen level.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2022.
- Individual participant dataSharing planned: Undecided. results of noxturnal oximetry, patients demographics.
Related trials for Obstructive Sleep Apnea
RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
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A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
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Recruiting
Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
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RecruitingPhase 1/2
DRonabinol Treatment of OSA
Obstructive Sleep Apnea
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea and Diabetes Mellitus, Type 2, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
correlation between nocturnal oxygen desaturation and glycemic control (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2022.