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We hypothesize that patients with untreated OSAS will have more visceral fat, fatty liver and increased carotid artery thickness whereas treatment with CPAP may reduce the mesenteric and liver fat, plasma lipids, carotid artery thickness.
This proposed randomized control trial (RCT) will compare the effects of therapeutic CPAP versus subtherapeutic CPAP in patients newly diagnosed with OSA with reference to visceral fat especially mesenteric fat thickness, liver fat, carotid artery intima media thickness (IMT), lateral pharyngeal wall (LPW) thickness, plasma lipids and adipokines over a treatment period of 3 months. The results of this study will advance our understanding of the relative role of OSA and obesity in the pathogenesis of metabolic syndrome (MetS) and whether CPAP therapy can improve these metabolic dysregulation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Therapeutic CPAP | Active Comparator | Therapeutic CPAP |
|
| control | Sham Comparator | subtherapeutic CPAP using 4 cm water |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CPAP | Device | All subjects will undergo ultrasound examination of the abdomen the day after overnight polysomnography (PSG) and then at 3 months after completion of therapeutic or subtherapeutic CPAP treatment of 4 cm water. |
| Measure | Description | Time Frame |
|---|---|---|
| Mesenteric Fat Thickness | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Changes in Adiponectin Over 3 Months | Mean changes in Adiponectin from baseline to 3 months. | Baseline, 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Hours of CPAP Usage Per Day | Mean Hours of CPAP usage per day in those who continue to use CPAP during the three month period. | 3 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hui David, MD | Chinese University of Hong Kong | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Respiratory Division | Hong Kong | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27933703 | Derived | Ng SS, Liu EK, Ma RC, Chan TO, To KW, Chan KK, Ngai J, Yip WH, Ko FW, Wong CK, Hui DS. Effects of CPAP therapy on visceral fat thickness, carotid intima-media thickness and adipokines in patients with obstructive sleep apnoea. Respirology. 2017 May;22(4):786-792. doi: 10.1111/resp.12963. Epub 2016 Dec 9. |
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51 subjects were excluded as 26 had AHI <5 events/hour and 25 were not interested in continuing study.
Subjects were recruited from patients referred by general practitioners to the respiratory clinics with clinical suspicion of sleep-disordered breathing over the period 17 Feb 2012 to 30 Oct 2013. Overnight polysomnography (PSG) were performed as inpatient at the hospital.
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| ID | Title | Description |
|---|---|---|
| FG000 | Therapeutic CPAP | The continuous positive airway pressure (CPAP) level for each patient in the arm was set at the minimum pressure needed to abolish snoring, obstructive respiratory events and airflow limitation for 95% of the night, as determined by the overnight CPAP titration study. |
| FG001 | Control | subtherapeutic CPAP using 4 cm water |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Therapeutic CPAP | The CPAP level for each patient in the arm was set at the minimum pressure needed to abolish snoring, obstructive respiratory events and airflow limitation for 95% of the night, as determined by the overnight CPAP titration study. |
| BG001 | Control |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mesenteric Fat Thickness | Posted | Mean | Standard Deviation | cm | 3 months |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Therapeutic CPAP | The CPAP level for each patient in the therapeutic CPAP arm was set at the minimum pressure needed to abolish snoring, obstructive respiratory events and airflow limitation for 95% of the night, as determined by the overnight CPAP titration study. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof David SC Hui | Chinese University of Hong Kong | 2632 3134 | dschui@cuhk.edu.hk |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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subtherapeutic CPAP using 4 cm water |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Neck circumference (cm) | Mean | Standard Deviation | cm |
|
| BMI (kg/m2) | Mean | Standard Deviation | kg/m2 |
|
| Epworth Sleepiness Scale (ESS) | minimum score of the scale is 0 and maximum is 24. The higher the score the sleepier the subject is. | Mean | Standard Deviation | units on a scale |
|
| Systolic blood pressure | Mean | Standard Deviation | mmHg |
|
| Diastolic blood pressure | Mean | Standard Deviation | mmHg |
|
| Apnea hypopnea index (AHI) (event/hour) | Mean | Standard Deviation | event/hour |
|
| Mesenteric fat thickness | Mean | Standard Deviation | cm |
|
| Adiponectin | Mean | Standard Deviation | ug/ml |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Mean Changes in Adiponectin Over 3 Months | Mean changes in Adiponectin from baseline to 3 months. | Posted | Mean | Standard Deviation | ug/ml | Baseline, 3 months |
|
|
|
| Other Pre-specified | Mean Hours of CPAP Usage Per Day | Mean Hours of CPAP usage per day in those who continue to use CPAP during the three month period. | Posted | Mean | Standard Deviation | hours | 3 months |
|
|
|
| 0 |
| 45 |
| 0 |
| 45 |
| EG001 | Control | subtherapeutic CPAP using 4 cm water | 0 | 45 | 0 | 45 |
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| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |