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Obstructive Sleep Apnoea and CPAP Treatment Response in Patients With Non-alcoholic Fatty Liver Disease

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ClinicalTrials.gov Identifier: NCT02728765
Recruitment Status : Completed
First Posted : April 5, 2016
Last Update Posted : May 7, 2019
Sponsor:
Information provided by (Responsible Party):
Prof David Shu Cheong Hui, Chinese University of Hong Kong

Brief Summary:

To study the frequency of obstructive sleep apnea (OSA) and continuous positive airway pressure (CPAP) treatment response in patients with non-alcoholic fatty liver disease (NAFLD).

It is hypothesized that CPAP treatment may improve the activities of NAFLD in those with concomitant OSA.

A screening study for OSA followed by a randomized controlled trial of patients with biopsy proven NAFLD being followed up at the hepatology clinic.

Home sleep study, Epworth sleepiness score (ESS), paired proton magnetic resonance spectroscopy (MRS), transient elastography by fibroscan, serum cytokeratin-18 fragment, liver function tests and liver biopsy (only for those with fibroscan evidence of advanced liver fibrosis).

Patients with confirmed symptomatic OSA will be randomized to receive auto CPAP or subtherapeutic CPAP as control over 6 months.

Primary outcome: changes in intrahepatic triglyceride content (IHTG) measured by proton-MRS after 6 months of auto CPAP versus subtherapeutic CPAP.


Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea Non-alcoholic Fatty Liver Disease Device: Continuous positive airway pressure (CPAP) Not Applicable

Detailed Description:

Investigators propose to screen for obstructive sleep apnea (OSA) by performing a home sleep study on all the patients with biopsy proven non-alcoholic fatty liver disease (NAFLD) being followed up at the Hepatology Clinic, Prince of Wales Hospital, Hong Kong, in phase one of this study. The following conditions have already been excluded as the underlying cause of liver disease in this specific NAFLD cohort: history of excessive alcoholic consumption (more than 30 g/day for men and 20 g/day for women), secondary causes of hepatic steatosis (such as chronic use of systemic corticosteroids), positive hepatitis B surface antigen, anti-hepatitis C virus antibody, or histological evidence of other concomitant chronic liver diseases.

OSA syndrome is defined by apnoea-hypopnoea index (AHI) of 5 per hours or more of sleep plus excessive daytime sleepiness or two of the following symptoms: choking or gasping during sleep, recurrent awakenings from sleep, unrefreshed sleep, daytime fatigue, and impaired concentration. All patients with suspected OSA will undergo initial assessment at the respiratory clinic with the Epworth sleepiness score (ESS) and symptoms evaluation. Patients who have ESS score >9 or at least two OSA symptoms as described above will be invited to join phase two of the study. They will be invited to undergo a home sleep study.

Those with biopsy proven NAFLD who have AHI≥ 5/hr will be randomized into either group A ) auto CPAP with range 4-12 cmH20 or group B) Subtherapeutic CPAP with the auto CPAP fixed at 4 cmH20 by a balanced block design by a third party not involved in the trial.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Obstructive Sleep Apnoea and CPAP Treatment Response in Patients With Non-alcoholic Fatty Liver Disease
Actual Study Start Date : July 5, 2016
Actual Primary Completion Date : March 30, 2019
Actual Study Completion Date : March 30, 2019


Arm Intervention/treatment
Active Comparator: auto CPAP
Each patient will be interviewed by the physician on duty and invited to participate in the overnight hospital based auto continuous positive airway pressure (CPAP) titration study for 1 night and then commencement of auto CPAP treatment for 6 months.
Device: Continuous positive airway pressure (CPAP)
Continuous positive airway pressure (CPAP) is the gold standard treatment for patients with obstructive sleep apnea (OSA). In a previous trials comparing therapeutic CPAP vs subtherapeutic CPAP, CPAP could reduce 24-hour mean blood pressure in mildly sleepy patients with OSA over 3 months whereas our one-year prospective study has shown that reduction of carotid artery intima-media thickness of OSA patients occurred mostly in the first 6 months and was sustained at 12 months in patients with CPAP compliance about 4.7 hours per night.

Placebo Comparator: Subtherapeutic CPAP
Following detection of obstructive sleep apnea (OSA), each patient randomized to this arm will receive the same CPAP education, mask fitting and short auto CPAP trial for acclimatization but their auto CPAP device will be set at a subtherapeutic level of 4 cmH20 for use at home. The patients randomized to both arms will receive the same general education about OSA, sleep hygiene, avoidance of alcohol, and weight reduction if appropriate.
Device: Continuous positive airway pressure (CPAP)
Continuous positive airway pressure (CPAP) is the gold standard treatment for patients with obstructive sleep apnea (OSA). In a previous trials comparing therapeutic CPAP vs subtherapeutic CPAP, CPAP could reduce 24-hour mean blood pressure in mildly sleepy patients with OSA over 3 months whereas our one-year prospective study has shown that reduction of carotid artery intima-media thickness of OSA patients occurred mostly in the first 6 months and was sustained at 12 months in patients with CPAP compliance about 4.7 hours per night.




Primary Outcome Measures :
  1. Changes in intrahepatic triglyceride content (IHTG) [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Changes in Epworth Sleepiness Score [ Time Frame: 6 months ]
  2. Transient elastography by fibroscan [ Time Frame: 6 months ]
  3. Serum cytokeratin-18 fragment [ Time Frame: 6 months ]
  4. Change in non-alcoholic fatty liver disease(NAFLD) activity score [ Time Frame: 6 months ]


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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • symptoms of obstructive sleep apnea with home sleep study showing apnea hypopnea index of 5/hour or more, subjects with non-alcoholic fatty liver disease (NAFLD) diagnosed by liver biopsy.

Exclusion Criteria:

  • (a) unstable cardiovascular diseases (e.g. recent unstable angina, myocardial infarction, stroke or transient ischemic attack within the previous 6 months or severe left ventricular failure), (b) neuromuscular disease affecting or potentially affecting respiratory muscles,(c) moderate to severe respiratory disease (i.e. breathlessness affecting activities of daily living) or documented hypoxemia or awake oxygen saturation <92% or (d) psychiatric disease that limits the ability to give informed consent or complete the study, (e) professional drivers, (f) gross structural ear-nose-throat abnormalities (large nasal polyps, gross nasal turbinate hypertrophy or septal deviation and enlarged "kissing" tonsils of significant size) who need early intervention.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02728765


Locations
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Hong Kong
Prince of Wales Hospital
Hong Kong, Hong Kong
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
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Principal Investigator: David SC Hui, MD Chinese University of Hong Kong
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Prof David Shu Cheong Hui, Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT02728765    
Other Study ID Numbers: Fatty liver/OSA/2016
First Posted: April 5, 2016    Key Record Dates
Last Update Posted: May 7, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Digestive System Diseases