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

• Sponsor: University Hospital, Ghent (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01368718
• Collaborator: (none)
• Enrollment: 55
• Location: 1
• Arm: 1
• Duration (Months): 38
• Patients Per Site Per Month: 1.4

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	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 Design

• Study Type: Interventional
• Anticipated Enrollment: 55 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Care Provider)
• Primary Purpose: Treatment
• Official Title: The Effect of Nasal CPAP in Patients With Chronic Fatigue and Sleep-disordered Breathing
• Study Start Date: Oct 1, 2012
• Anticipated Primary Completion Date: Dec 1, 2015
• Anticipated Study Completion Date: Dec 1, 2015

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Continuous Positive Airway Pressure-responsiveness regarding fatigue after 28 days: baseline evaluation. [At day 0]

   Baseline evaluation before treatment. Questionnaires Fatigue Severity Scale (FSS), Checklist Individual Strength(CIS), Visual Analogue Scale for Fatigue (VAS-F) are used.

2. Continuous Positive Airway Pressure-responsiveness regarding fatigue after 28 days: first treatment + effect evaluation. [Treatment takes 28 days after first 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.

3. Continuous Positive Airway Pressure-responsiveness regarding fatigue after 28 days: second treatment + effect evaluation. [Treatment takes 28 days after second 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.

Secondary Outcome Measures

1. The Continuous Positive Airway Pressure responsiveness regarding sleepiness and general health in the same target population: baseline evaluation. [At day 0]

   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.

2. The Continuous Positive Airway Pressure responsiveness regarding sleepiness and general health in the same target population: first treatment + effect evaluation. [Treatment takes 28 days after first 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.

3. The Continuous Positive Airway Pressure responsiveness regarding sleepiness and general health in the same target population: second treatment + effect evaluation. [Treatment takes 28 days after second 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Ghent University Hospital	Ghent		Belgium	9000

Sponsors and Collaborators

• University Hospital, Ghent

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital, Ghent
• ClinicalTrials.gov Identifier: NCT01368718
• Other Study ID Numbers: 2011/191
• First Posted: Jun 8, 2011
• Last Update Posted: Jun 3, 2015
• Last Verified: Jun 1, 2015

• Additional relevant MeSH terms: Fatigue Syndrome, Chronic; Sleep Apnea Syndromes; Fatigue

Study Results

No Results Posted as of Jun 3, 2015