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

The Effect of Nasal CPAP in Patients With Chronic Fatigue and Sleep-disordered Breathing

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.

Study Overview

• Status: Terminated
• Conditions: Chronic Fatigue With OSA; Chronic Fatigue Syndrome With OSA
• Intervention / Treatment: Procedure: Active CPAP is compared with sham CPAP as a control intervention.

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Phase 4

Contacts and Locations

Study Locations

• Belgium
  • Ghent, Belgium, 9000
    • Ghent University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Continuous Positive Airway Pressure-responsiveness regarding fatigue after 28 days: baseline evaluation.	Baseline evaluation before treatment. Questionnaires Fatigue Severity Scale (FSS), Checklist Individual Strength(CIS), Visual Analogue Scale for Fatigue (VAS-F) are used.	At day 0
Continuous Positive Airway Pressure-responsiveness regarding fatigue after 28 days: first treatment + effect evaluation.	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.	Treatment takes 28 days after first evaluation
Continuous Positive Airway Pressure-responsiveness regarding fatigue after 28 days: second treatment + effect evaluation.	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.	Treatment takes 28 days after second evaluation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Continuous Positive Airway Pressure responsiveness regarding sleepiness and general health in the same target population: baseline evaluation.	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.	At day 0
The Continuous Positive Airway Pressure responsiveness regarding sleepiness and general health in the same target population: first treatment + effect evaluation.	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.	Treatment takes 28 days after first evaluation
The Continuous Positive Airway Pressure responsiveness regarding sleepiness and general health in the same target population: second treatment + effect evaluation.	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.	Treatment takes 28 days after second evaluation

Collaborators and Investigators

• Sponsor: University Hospital, Ghent
• Investigators: Principal Investigator: An Mariman, MD, University Hospital, Ghent

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2012
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): April 11, 2017

Study Registration Dates

• First Submitted: June 6, 2011
• First Submitted That Met QC Criteria: June 7, 2011
• First Posted (Estimate): June 8, 2011

Study Record Updates

• Last Update Posted (Estimate): December 15, 2022
• Last Update Submitted That Met QC Criteria: December 14, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Virus Diseases; Infections; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Diseases; Encephalomyelitis; Sleep Apnea Syndromes; Fatigue; Fatigue Syndrome, Chronic
• Other Study ID Numbers: 2011/191