Effects of CPAP on Cognitive Function, Neurocognitive Architecture and Function in Patients With OSA: The SMOSAT Trial
Condition: Apnea, Sleep
MeSH terms: Sleep Apnea Syndromes
Study type: Interventional

Summary: 
      Multiple clinical studies have indicated that obstructive sleep apnea (OSA), the most common
      chronic sleep disorder, may affect neurocognitive function, and that treatment for continuous
      positive airway pressure (CPAP) has some neurocognitive protective effects against the
      adverse effects of OSA. However, the effects of CPAP treatment on neurocognitive architecture
      and function remain unclear. Therefore, this multicenter trial was designed to investigate
      whether and when neurocognitive architecture and function in patients with OSA can be
      improved by CPAP treatment, and to explore the role of gut microbiota in improving
      neurocognitive function during treatment.This study will be a multicenter, randomized,
      controlled trial with allocation concealment and assessor blinding. A total of 148 eligible
      patients with severe OSA will be enrolled from five sleep centers, and randomized to receive
      CPAP with best supportive care (BSC) intervention or BSC intervention alone. Cognitive
      function, structure and function of brain regions, gut microbiota, metabolites, biochemical
      variables, electrocardiography, echocardiography, pulmonary function, and arterial stiffness
      will be assessed at baseline before randomization and at 3, 6, and 12 months. In addition,
      the investigators will enroll 74 healthy controls and assess all of the aforementioned
      variables at baseline.
    

Detailed description: 
      Background Multiple clinical studies have indicated that obstructive sleep apnea (OSA), the
      most common chronic sleep disorder, may affect neurocognitive function, and that treatment
      for continuous positive airway pressure (CPAP) has some neurocognitive protective effects
      against the adverse effects of OSA. However, the effects of CPAP treatment on neurocognitive
      architecture and function remain unclear. Therefore, this multicenter trial was designed to
      investigate whether and when neurocognitive architecture and function in patients with OSA
      can be improved by CPAP treatment, and to explore the role of gut microbiota in improving
      neurocognitive function during treatment.

      Methods/Design This study will be a multicenter, randomized, controlled trial with allocation
      concealment and assessor blinding. A total of 148 eligible patients with severe OSA will be
      enrolled from five sleep centers, and randomized to receive CPAP with best supportive care
      (BSC) intervention or BSC intervention alone. Cognitive function, structure and function of
      brain regions, gut microbiota, metabolites, biochemical variables, electrocardiography,
      echocardiography, pulmonary function, and arterial stiffness will be assessed at baseline
      before randomization and at 3, 6, and 12 months. In addition, the investigators will enroll
      74 healthy controls and assess all of the aforementioned variables at baseline.

      Ethics and Dissemination Ethics approval was given by the Medical Ethics Committee of
      Shanghai Jiao Tong University Affiliated Sixth People's Hospital (approval number 2015-79).
      The findings from this study will be disseminated in peer-reviewed journals and at
      conferences.
    

Intervention name(s): CPAP; BSC
Intervention type(s): Device; Dietary Supplement
Intervention description(s): CPAP plus BSC group Participants in the CPAP plus BSC group will receive CPAP treatment plus the aforementioned BSC intervention. CPAP treatment (LOTUS AUTO; Curative Medical Technology Inc., Beijing, China) will be initiated using standard clinical practice at each center. Participants in both groups will be asked to continue their usual medical care during the trial.; BSC only group Participants in the BSC only group will receive advice regarding lifestyle modification, sleep hygiene, naps, exercise, caffeine, and diet, and avoiding alcohol consumption, but no specific weight loss program, diet, or salt restriction will be suggested.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: OSA; CPAP; cognitive function; gut microbiota; metabolomics