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

NCT02728765 | Completed DMC

• 1 other identifier: Fatty liver/OSA/2016
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea; Non-alcoholic Fatty Liver Disease

Outcome Measures

Primary Outcomes (1)

• Changes in intrahepatic triglyceride content (IHTG)

  6 months

Secondary Outcomes (4)

• Changes in Epworth Sleepiness Score

  6 months

• Transient elastography by fibroscan

  6 months

• Serum cytokeratin-18 fragment

  6 months

• Change in non-alcoholic fatty liver disease(NAFLD) activity score

  6 months

Study Arms (2)

auto CPAP

ACTIVE COMPARATOR

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)

Subtherapeutic CPAP

PLACEBO COMPARATOR

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)

Interventions

Continuous positive airway pressure (CPAP) DEVICE

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.

Subtherapeutic CPAP; auto CPAP

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Non-alcoholic Fatty Liver Disease

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Fatty Liver; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• David SC Hui, MD

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 31, 2016
• First Posted: April 5, 2016
• Study Start: July 5, 2016
• Primary Completion: March 30, 2019
• Study Completion: March 30, 2019
• Last Updated: May 7, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)