Prevalence of Metabolic Syndrome in Obstructive Sleep Apnea (OSA) and Effect of Treatment With Continuous Positive Airway Pressure (Auto-CPAP) on Metabolic Syndrome
Condition: Obstructive Sleep Apnea; Metabolic Syndrome
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Metabolic Syndrome; Syndrome
Study type: Interventional

Summary: 
      Metabolic syndrome is a constellation of risk factors for cardiovascular disease. The
      prevalence of metabolic syndrome in persons with obstructive sleep apnea syndrome (OSAS) is
      known to be very high, about 70%. However, it is unclear whether this association is causal
      or not. Results of earlier studies have been conflicting. The investigators hypothesize that
      treatment with auto-titrating continuous positive airway pressure (auto-CPAP) for a duration
      of 3 months improves the metabolic syndrome in subjects with OSAS.
    

Detailed description: 
      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.
    

Intervention name(s): AutoSet Spirit; Modified-AutoSet Spirit
Intervention type(s): Device; Device
Intervention description(s): 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 non-therapeutic sham-CPAP followed by 3 months of therapeutic CPAP (auto-titrating CPAP) with 1 month of wash-out in between
Other intervention name(s): AutoSet Spirit(TM), ResMed India Ltd.; Modified-AutoSet Spirit(TM), ResMed India Ltd.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Obstructive sleep apnea; Metabolic syndrome; Insulin resistance; Hypertension; Dyslipidemia; Continuous positive airway pressure (CPAP)