Effects of CPAP on Cognitive Function, Neurocognitive Architecture and Function in Patients With OSA: The SMOSAT Trial

NCT02886156 | Completed DMC

• 1 other identifier: 6thShanghaiJiaotongU2
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Apnea, Sleep

Keywords

OSA; CPAP; cognitive function; gut microbiota; metabolomics

Outcome Measures

Primary Outcomes (1)

• Changes from baseline neurocognitive function in participants at 3 month,6 month,1 year follow-up as measured by montreal cognitive assessment-score range 0-30

  Assessment of neurocognitive function by montreal cognitive assessment-score range 0-30

  baseline,month 3, month 6 and year 1

Secondary Outcomes (11)

• Changes from baseline daytime sleepiness and sleep variables in participants at 3 month, 6 month and 1 year follow-up as measured by polysomnography (PSG)

  baseline,month 3, month 6 and year 1

• Changes from baseline neurocognitive function in participants at 3 month, 6 month and 1 year follow-up as measured by central auditory processing testing

  baseline,month 3, month 6 and year 1

• Changes from baseline neurocognitive function in participants at 3 month, 6 month and 1 year follow-up as measured by 256-channel high-density electroencephalography (EEG) recordings

  baseline,month 3, month 6 and year 1

• Changes from baseline gut microbiomes in stool specimens in participants at 3 month, 6 month and 1 year follow-up as measured through metagenomic analysis

  baseline,month 3, month 6 and year 1

• Changes from baseline metabolomics profiling in participants at 3 month, 6 month and 1 year follow-up as measured by metabolomics approach

  baseline,month 3, month 6 and year 1

Study Arms (2)

CPAP plus BSC

EXPERIMENTAL

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.

Device: CPAP; Dietary Supplement: BSC

BSC intervention

ACTIVE COMPARATOR

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.

Dietary Supplement: BSC

Interventions

CPAP DEVICE

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.

CPAP plus BSC

BSC DIETARY_SUPPLEMENT

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.

BSC intervention; CPAP plus BSC

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed consent
• Age 30-65 years
• Newly diagnosed OSA (full-night in-laboratory polysomnography \[PSG\] with AHI ≥ 15 events per hour)
• Adherence to CPAP treatment
• No participation in any other clinical trial in the past 3 months
• Able to accomplish relevant tests and follow-up

You may not qualify if:

• Severe systemic diseases (e.g., cardiac, hepatic, and renal failure)
• Psychiatric conditions (e.g., depression, mania, schizophrenia)
• Neurological diseases (e.g., head trauma, brain tumor, epilepsy, stroke, transient ischemic attack, coma)
• Sleep disorders other than OSA (narcolepsy, insomnia, chronic sleep deprivation, rapid eye movement \[REM\] behavior disorder and restless legs syndrome, central sleep apnea or obesity hypoventilation syndrome)
• Alcoholism, drug addiction, use of psychotropic drugs, sedatives, or narcotics
• Prior therapy for OSA (i.e., CPAP, upper airway surgery, oral appliance)
• Minimum Mental State Examination (MMSE)\< 24
• Left-handed
• MRI contraindications (e.g., claustrophobic or metal implantation)
• Gastrointestinal surgery during the last year, except for appendicitis and hernia surgery
• Pregnancy
• Use of intestinal flora regulator (e.g., antibiotics or probiotics) in the previous 8 weeks
• Medical treatment for cholecystitis, gallstones, gastrointestinal ulcers, urinary tract infection, acute pyelonephritis, or cystitis in the past 3 months
• Infectious diseases, such as tuberculosis, acquired immune deficiency syndrome
• Commercial drivers or people deemed to be at risk of driving -related accidents

Sponsors & Collaborators

• Shanghai Jiao Tong University Affiliated Sixth People's Hospital: lead

Study Sites (1)

Otolaryngological Institute of Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, 2002333, China

Location

Related Publications (5)

• Henderson LA, Fatouleh RH, Lundblad LC, McKenzie DK, Macefield VG. Effects of 12 Months Continuous Positive Airway Pressure on Sympathetic Activity Related Brainstem Function and Structure in Obstructive Sleep Apnea. Front Neurosci. 2016 Mar 10;10:90. doi: 10.3389/fnins.2016.00090. eCollection 2016.

  PMID: 27013952 BACKGROUND

• Dalmases M, Sole-Padulles C, Torres M, Embid C, Nunez MD, Martinez-Garcia MA, Farre R, Bargallo N, Bartres-Faz D, Montserrat JM. Effect of CPAP on Cognition, Brain Function, and Structure Among Elderly Patients With OSA: A Randomized Pilot Study. Chest. 2015 Nov;148(5):1214-1223. doi: 10.1378/chest.15-0171.

  PMID: 26065720 BACKGROUND

• Rosenzweig I, Glasser M, Crum WR, Kempton MJ, Milosevic M, McMillan A, Leschziner GD, Kumari V, Goadsby P, Simonds AK, Williams SC, Morrell MJ. Changes in Neurocognitive Architecture in Patients with Obstructive Sleep Apnea Treated with Continuous Positive Airway Pressure. EBioMedicine. 2016 May;7:221-9. doi: 10.1016/j.ebiom.2016.03.020. Epub 2016 Mar 25.

  PMID: 27322475 BACKGROUND

• Xu H, Wang H, Guan J, Yi H, Qian Y, Zou J, Xia Y, Fu Y, Li X, Jiao X, Huang H, Dong P, Yu Z, Yang J, Xiang M, Li J, Chen Y, Wang P, Sun Y, Li Y, Zheng X, Jia W, Yin S. Effects of continuous positive airway pressure on neurocognitive architecture and function in patients with obstructive sleep apnoea: study protocol for a multicentre randomised controlled trial. BMJ Open. 2017 May 25;7(5):e014932. doi: 10.1136/bmjopen-2016-014932.

  PMID: 28550021 BACKGROUND

• Xu H, Liu Y, Li C, Li X, Shen L, Wang H, Liu F, Zou J, Xia Y, Huang W, Liu Y, Gao Z, Fu Y, Wang F, Huang S, Song Z, Song F, Gao Y, Peng Y, Zou J, Zhu H, Liu S, Li L, Zhu X, Xiong Y, Hu Y, Yang J, Li Y, Gao F, Guo Q, Huang H, Zhang W, Li J, Chen Y, Dong P, Yang J, Lv J, Wang P, Sun Y, Qian B, Yaffe K, Guan J, Yi H, Leng Y, Yin S. Effects of Continuous Positive Airway Pressure on Neuroimaging Biomarkers and Cognition in Adult Obstructive Sleep Apnea: A Randomized Controlled Trial. Am J Respir Crit Care Med. 2025 Apr;211(4):628-636. doi: 10.1164/rccm.202406-1170OC.

  PMID: 39998447 DERIVED

MeSH Terms

Conditions

Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Shankai Yin, MD, Ph D

  Shanghai Jiao Tong University Affiliated Sixth People's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Residents

Study Record Dates

• First Submitted: August 3, 2016
• First Posted: September 1, 2016
• Study Start: April 4, 2017
• Primary Completion: December 30, 2021
• Study Completion: December 30, 2021
• Last Updated: March 2, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After 2019
• Access Criteria: Research institutions

Locations

CN (1)