- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00694616
Prevalence of Metabolic Syndrome in Obstructive Sleep Apnea (OSA) and Effect of Treatment With Continuous Positive Airway Pressure (Auto-CPAP) on Metabolic Syndrome
Prevalence of Metabolic Syndrome in Obstructive Sleep Apnea and the Effect of Treatment With Auto-titrating Continuous Positive Airway Pressure (Auto-CPAP) on Metabolic Syndrome
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Obstructive sleep apnea (OSA) is a condition in which there is collapse of the upper airway during sleep, as a result of which there is a decrease or complete cessation of airflow. This leads to repeated episodes of hypoxia during sleep and sleep fragmentation. OSA is a highly prevalent though under-recognized clinical problem. The Wisconsin study estimated a prevalence of 24% in males and 9% in females. A population-based study in Delhi, India found the prevalence of OSA to be 13.7% and that of obstructive sleep apnea syndrome (OSAS) to be 3.8%.
OSA is associated with various systemic complications such as neurocognitive dysfunction, cardiovascular disease, insulin resistance, and dyslipidemia. There is an increased risk of motor vehicle and occupational accidents in people suffering from OSAS.
Metabolic syndrome is the co-occurrence of several cardiovascular risk factors such as abdominal obesity, hypertension, impaired glucose tolerance and dyslipidemia. Presence of OSA together with metabolic syndrome is known as 'Syndrome Z'. Although many studies have shown that OSA is associated with metabolic syndrome, the exact causal relationship between these two entities is not proven.
Continuous positive airway pressure (CPAP) is the standard treatment for OSA with significant symptoms. However, it is a costly treatment option, and poor compliance is an important limiting factor. CPAP treatment has been shown to improve the daytime somnolence and neurocognitive function in people with OSAS. However, its effect on metabolic syndrome in people with OSAS is unclear.
This study aims to assess the effect of CPAP treatment on metabolic syndrome in patients with OSAS.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
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New Delhi, Indien, 110608
- All India Institute of Medical Sciences
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Subjects with moderately severe OSAS (AHI >= 15 with excessive daytime sleepiness) also having metabolic syndrome, and have never received treatment for OSAS, diabetes mellitus and hypertension
Exclusion Criteria:
Diabetic subjects will be excluded if any one of the following is present
- Proliferative diabetic retinopathy
- Nephropathy (serum creatinine >1.8 mg/dL)
- Clinically manifest neuropathy defined as absent ankle jerks.
- Severe hyperglycemia (FBS >200 mg/dL)
Hypertensive subjects will be excluded if any one of the following is present
- Symptomatic coronary artery disease
- Symptomatic peripheral vascular disease
- Past history of cerebrovascular accident
- Known case of aortic aneurysm or left ventricular dysfunction
- Nephropathy (serum creatinine >1.8 mg/dL)
- Marked elevation in blood pressure (BP >180/110 mm Hg on two occasions)
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Andet: 2
3 months of non-therapeutic sham-CPAP followed by 3 months of therapeutic CPAP (auto-titrating CPAP) with 1 month of wash-out in between
|
3 months of non-therapeutic sham-CPAP followed by 3 months of therapeutic CPAP (auto-titrating CPAP) with 1 month of wash-out in between
Andre navne:
|
Andet: 1
3 months of therapeutic CPAP (auto-titrating CPAP) followed by 3 months of non-therapeutic sham-CPAP with 1 month of wash-out in between
|
3 months of therapeutic CPAP (auto-titrating CPAP) followed by 3 months of non-therapeutic sham-CPAP with 1 month of wash-out in between
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Proportion of subjects satisfying the National Cholesterol Education Program-Adult Treatment Panel (NCEP-ATP III) criteria for the diagnosis of metabolic syndrome
Tidsramme: 3 months
|
3 months
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Individual components of the NCEP-ATP III criteria (FBS, BP, LDL cholesterol, HDL cholesterol, triglycerides) and insulin resistance (assessed by HOMA-IR)
Tidsramme: 3 months
|
3 months
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Surendra K Sharma, M.D., Ph.D., All India Institute of Medical Sciences, New Delhi
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Patologiske processer
- Glukosemetabolismeforstyrrelser
- Metaboliske sygdomme
- Sygdomme i nervesystemet
- Luftvejssygdomme
- Respirationsforstyrrelser
- Søvnforstyrrelser, iboende
- Dyssomnier
- Søvnvågningsforstyrrelser
- Sygdom
- Tegn og symptomer, luftveje
- Insulin resistens
- Hyperinsulinisme
- Søvnapnø syndromer
- Søvnapnø, obstruktiv
- Syndrom
- Apnø
- Metabolisk syndrom
Andre undersøgelses-id-numre
- SKS/OSA/CPAP/2008
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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