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Nasal Continuous Positive Airway Pressure (CPAP) in Chronic Fatigue and Sleep-disordered Breathing

This study is not yet open for participant recruitment.
Verified August 2012 by University Hospital, Ghent
Sponsor:
Information provided by (Responsible Party):
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT01368718
First received: June 6, 2011
Last updated: August 8, 2012
Last verified: August 2012
  Purpose

Chronic fatigue (CF) and chronic fatigue syndrome (CFS) are disabling disorders that may be induced or aggravated by underlying sleep disturbances. The relationship between sleep quality and fatigue is still not fully elucidated. To evaluate the effect of improved sleep quality on fatigue, a randomized controlled and cross-over trial with nasal continuous positive airway pressure (nCPAP) is carried out in patients who present with a primary complaint of chronic disabling fatigue and who are found to have an apnea-hypopnea index (AHI) >= 15 on polysomnography (PSG).

The aim of this study is to address the issue of Continuous Positive Airway Pressure-responsiveness regarding fatigue as a presenting symptom in CF and CFS patient with obstructive sleep apnea (OSA), in the absence of underlying medical or psychiatric illness. The answer to this question may shed further light on the enigmatic relationship between sleep and fatigue. We also want to investigate the Continuous Positive Airway Pressure responsiveness regarding sleepiness and general health in the same target population. Zero-hypothesis: there is no effect.


Condition Intervention Phase
Chronic Fatigue With OSA
Chronic Fatigue Syndrome With OSA
Procedure: Active CPAP is compared with sham CPAP as a control intervention.
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: The Effect of Nasal CPAP in Patients With Chronic Fatigue and Sleep-disordered Breathing

Resource links provided by NLM:


Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:
  • Continuous Positive Airway Pressure-responsiveness regarding fatigue after 28 days: baseline evaluation. [ Time Frame: At day 0 ] [ Designated as safety issue: No ]
    Baseline evaluation before treatment. Questionnaires Fatigue Severity Scale (FSS), Checklist Individual Strength(CIS), Visual Analogue Scale for Fatigue (VAS-F) are used.

  • Continuous Positive Airway Pressure-responsiveness regarding fatigue after 28 days: first treatment + effect evaluation. [ Time Frame: Treatment takes 28 days after first evaluation ] [ Designated as safety issue: No ]
    At the end of the first treatment: effect evaluation. Questionnaires Fatigue Severity Scale (FSS), Checklist Individual Strength(CIS), Visual Analogue Scale for Fatigue (VAS-F) are used.

  • Continuous Positive Airway Pressure-responsiveness regarding fatigue after 28 days: second treatment + effect evaluation. [ Time Frame: Treatment takes 28 days after second evaluation ] [ Designated as safety issue: No ]
    At the end of the second treatment: effect evaluation. Questionnaires Fatigue Severity Scale (FSS), Checklist Individual Strength(CIS), Visual Analogue Scale for Fatigue (VAS-F) are used.


Secondary Outcome Measures:
  • The Continuous Positive Airway Pressure responsiveness regarding sleepiness and general health in the same target population: baseline evaluation. [ Time Frame: At day 0 ] [ Designated as safety issue: No ]
    Before treatment: baseline evaluation. Polysomnography Test (PSG) , Multiple Sleep Latency Test (MSLT) and questionnaires ( Epworth Sleepiness Scale (ESS), Pittsburgh Sleep Quality Index (PSQI), Medical Outcomes Study Short Form 36-item (MOS SF36)) are used.

  • The Continuous Positive Airway Pressure responsiveness regarding sleepiness and general health in the same target population: first treatment + effect evaluation. [ Time Frame: Treatment takes 28 days after first evaluation ] [ Designated as safety issue: No ]
    At the end of the first treatment: effect evaluation. Polysomnography Test (PSG) , Multiple Sleep Latency Test (MSLT) and questionnaires ( Epworth Sleepiness Scale (ESS), Pittsburgh Sleep Quality Index (PSQI), Medical Outcomes Study Short Form 36-item (MOS SF36)) are used.

  • The Continuous Positive Airway Pressure responsiveness regarding sleepiness and general health in the same target population: second treatment + effect evaluation. [ Time Frame: Treatment takes 28 days after second evaluation ] [ Designated as safety issue: No ]
    At the end of the second treatment: effect evaluation. Polysomnography Test (PSG) , Multiple Sleep Latency Test (MSLT) and questionnaires ( Epworth Sleepiness Scale (ESS), Pittsburgh Sleep Quality Index (PSQI), Medical Outcomes Study Short Form 36-item (MOS SF36)) are used.


Estimated Enrollment: 55
Study Start Date: October 2012
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active/Sham CPAP Procedure: Active CPAP is compared with sham CPAP as a control intervention.
Patients are randomized into active or control arm. After the first treatment, a washout period is installed,after which therapy is switched according to the cross-over protocol. A CPAP device consists of a unit that generates airflow, which is directed to the airway via a mask. With active CPAP, the generated airflow creates a positive pressure and prevents upper airway collapse. With sham CPAP, the generated airflow creates a very low pressure.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients primarily referred for disabling, unexpected fatigue.
  • According to the Fukuda criteria, diagnostic work-up yields a final diagnosis of chronic fatigue (CF) or chronic fatigue syndrome (CFS).
  • 18 <= age <= 65
  • Polysomnography Test (PSG) demonstrates an apnea-hypopnea index (AHI) >=15, as evidence for obstructive sleep apnea (OSA).
  • Female patient of childbearing potential (premenopausal female biologically capable of becoming pregnant) has a confirmed negative pregnancy test at the start of the Continuous Positive Airway Pressure (CPAP) trial and has to employ an acceptable method of birth control.
  • Written, signed and dated informed consent must be obtained from each patient.
  • Patient able to understand and follow the requirements of the study and to comply.
  • Willing to abstain from taking any medication or treatment prohibited in the protocol.

Exclusion Criteria:

  • Patients primarily referred for Excessive Daytime Sleepiness (EDS) or snoring.
  • Fatigue that is explained by medical or psychiatric causes.
  • 18 > age > 65
  • Apnea-Hypopnea Index (AHI) < 15
  • Body Mass Index (BMI) >= 40, calculated as weight(m)/(height (m))²
  • Parasomnia
  • Severe sleepiness with (Epworth Sleepiness Scale) ESS >= 16 (=15% of the Chronic fatigue syndrome (CFS) population)
  • Tonsillar hypertrophy (Friedman grade III and IV tonsils)
  • Signs of nasal obstruction, including chronic use of topical nasal drugs.
  • Earlier CPAP treatment
  • Physical and mental disability that compromises the normal use of CPAP
  • CPAP intolerance
  • Current use of sedative (benzodiazepine and non-benzodiazepine GABA-esgic agonist) or antidepressant medication for a time period inferior to 3 weeks.
  • Female patient who is pregnant, lactating or has a positive pregnancy test result.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01368718

Contacts
Contact: An Mariman, MD +3293223708 an.mariman@ugent.be

Locations
Belgium
Ghent University Hospital Not yet recruiting
Ghent, Belgium, 9000
Contact: An Mariman, MD         
Principal Investigator: An Mariman, MD         
Sponsors and Collaborators
University Hospital, Ghent
Investigators
Principal Investigator: An Mariman, MD Ghent University Hospital
  More Information

No publications provided

Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT01368718     History of Changes
Other Study ID Numbers: 2011/191
Study First Received: June 6, 2011
Last Updated: August 8, 2012
Health Authority: Belgium: Ethics Committee

Additional relevant MeSH terms:
Fatigue
Fatigue Syndrome, Chronic
Sleep Apnea Syndromes
Signs and Symptoms
Virus Diseases
Muscular Diseases
Musculoskeletal Diseases
Encephalomyelitis
Central Nervous System Diseases
Nervous System Diseases
Neuromuscular Diseases
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders

ClinicalTrials.gov processed this record on April 17, 2014