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

NCT ID: NCT01368718

Last Updated: 2022-12-15

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2017-04-11

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.

Conditions

Chronic Fatigue With OSA; Chronic Fatigue Syndrome With OSA

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Active/Sham CPAP

Group Type: OTHER

Active CPAP is compared with sham CPAP as a control intervention.

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Ghent

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

An Mariman, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Ghent

Locations

Ghent University Hospital

Ghent, , Belgium

Countries

Belgium

Other Identifiers

2011/191

Identifier Type: -

Identifier Source: org_study_id