Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01947634
Other study ID # SleepFabry
Secondary ID
Status Completed
Phase N/A
First received September 12, 2013
Last updated March 2, 2015
Start date September 2013
Est. completion date February 2015

Study information

Verified date February 2015
Source University of Zurich
Contact n/a
Is FDA regulated No
Health authority Switzerland: Swissmedic
Study type Interventional

Clinical Trial Summary

Prospective, observational cohort study to investigate the prevalence of sleepiness and sleep-related breathing disorders in patients with Fabry disease (FD). For this, an Epworth Sleepiness Score (ESS) and ambulatory overnight respiratory polygraphy (oRP) is obtained in all subjects.


Description:

There are 76 patients with Fabry disease in the region of eastern Switzerland who are observed and treated in the University Hospital Zurich. All patients are encountered in retrospective cohort study, and all patients are asked to participate in the study by obtaining written informed consent.

Eligible Fabry patients are investigated by completion of ESS and one ambulatory overnight respiratory polygraphy (oRP). An ESS over 11 is defined as excessive daytime sleepiness(EDS). An apnoea/hypopnoea index (AHI) over 5 per minute is defined as sleep apnoea. Distinction of obstructive sleep apnoea (OSA) and central sleep apnoea (CSA) is performed by analysis of oRP. Medical history, clinical and laboratory data, and current treatment will be extracted from patient files and the retrospective cohort study, respectively.

The patients are asked to participate in the study at clinically regular follow-up visits. After obtaining informed consent, the subjects are provided for reviewing in- and exclusion criteria. For this, additional laboratory analyses and completion of ESS and patient's health questionnaire (PHQ-9) is required.

The screening visit is encountered in the routine clinical follow-up examination. After obtaining informed consent, the subjects are provided for reviewing in- and exclusion criteria. For this, the laboratory results (s. exclusion criteria), which are part of the routine follow-up examination, are checked, and PHQ-9 and ESS are completed together with the patient.

In case of fulfilling all inclusion criteria without presence of exclusion criteria, the patients are scheduled by telephone call for visit 1 (oRP).

Eligible Fabry patients are investigated one ambulatory overnight respiratory polygraphy (oRP). For this reason, the subjects are asked to pick-up and learn the self-administration of the oRP device (ApneaLinkā„¢ Plus (ResMed)). The oRP itself is easily performed at subject's home. The following day, the patients need to return the device, or, alternatively, they can send it by post. After oRP, there is no need for further visits for purpose of the study. The subjects are informed about the results of oRP during the next regular clinical follow-up visit.

ORP is a non-invasive medical examination technique, which is routinely applied to detect sleep-related breathing disorders. For purpose of the oRP, the ApneaLinkā„¢ Plus (ResMed), a home sleep testing diagnostic device that provides simple, cost-effective and reliable results, is applied. The subjects will be instructed in the usage of the device, so that they can install themselves in the study night.


Recruitment information / eligibility

Status Completed
Enrollment 52
Est. completion date February 2015
Est. primary completion date January 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion criteria: Established diagnosis of Fabry disease, who

- are 18 years or above

- have signed informed consent.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic


Related Conditions & MeSH terms


Intervention

Other:
ResMed Apnea Link plus
Overnight respiratory polygraphy to detect sleep-related breathing disorders is performed in Fabry patients

Locations

Country Name City State
Switzerland University Hospital Zurich, Division of Internal Medicine Zurich ZH

Sponsors (1)

Lead Sponsor Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Prevalence and type of sleep-related breathing disorder in Fabry patients. Prevalence and type of sleep-related breathing disorder in Fabry patients measured with overnight ambulatory respiratory polygraphy. Day 1 No
See also
  Status Clinical Trial Phase
Recruiting NCT04893889 - Substudy (NCT04456582): Noninvasive Assessment of Myocardial Stiffness by 2D-SWE Ultrasound Technique (Two-dimensional Shear Wave Elastography) in Patients With Amyloidosis and Fabry Disease. N/A
Completed NCT04455230 - A Long Term Follow-Up Study of Fabry Disease Subjects Treated With FLT190 Phase 1/Phase 2
Completed NCT01218659 - Study to Compare the Efficacy and Safety of Oral AT1001 and Enzyme Replacement Therapy in Patients With Fabry Disease Phase 3
Completed NCT00304512 - A 12-Week Safety and Pharmacodynamic Study of AT1001 (Migalastat Hydrochloride) in Female Participants With Fabry Disease Phase 2
Withdrawn NCT04189601 - Complement Activation in the Lysosomal Storage Disorders
Completed NCT03500094 - Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of Migalastat in Pediatric Subjects (Aged 12 to <18 Years) Phase 3
Withdrawn NCT04143958 - To Assess the Glycosphingolipid Clearance and Clinical Effects of Switching to Agalsidase Beta (Fabrazyme) Versus Continuing on Agalsidase Alfa (Replagal) in Male Patients With Classic Fabry Disease Phase 4
Recruiting NCT02994303 - Podocyturia - Predictor of Renal Dysfunction in Fabry Nephropathy N/A
Recruiting NCT01695161 - Non-invasive Assessment of Intraocular Pressure in MPS by Use of the Ocular Response Analyzer. N/A
Completed NCT01853852 - A Phase I, Randomized, Single-Blind, Four-Period Cross-Over, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety and Pharmacokinetics of Single Oral Doses of GR181413A/AT1001 in Healthy Japanese Subjects Phase 1
Completed NCT00701415 - A Study of Two Fabrazyme (Agalsidase Beta) Dosing Regimens in Treatment-naïve, Male Pediatric Patients Without Severe Symptoms Phase 3
Completed NCT00068107 - Dosing Study of Replagal in Patients With Fabry Disease Phase 2
Completed NCT01997489 - Ophthalmic Findings During 10-year Enzyme Substitution of Danish Fabry Patients. Phase 4
Recruiting NCT06007768 - Autoimmune and Inflammatory Response Biomarkers in Fabry Disease
Recruiting NCT05698901 - Biomarkers and Cardiac Imaging Diagnostic Assay for Monitoring Patients With Fabry Disease
Active, not recruiting NCT03305250 - Arrhythmia Burden, Risk of Sudden Cardiac Death and Stroke in Patients With Fabry Disease N/A
Terminated NCT00526071 - Open-label Long-term Safety Study of AT1001 (Migalastat Hydrochloride) in Participants With Fabry Disease Who Have Completed a Previous AT1001 Study Phase 2
Active, not recruiting NCT03566017 - Open Label Extension Study of 1 mg/kg Pegunigalsidase Alfa Every 2 Weeks in Patients With Fabry Disease Phase 3
Recruiting NCT06065605 - Assess Urine Biomarkers to Predict Nephropathy in Fabry Disease
Recruiting NCT06052800 - Agalsidase Beta Long-Term Treatment Outcome for Fabry Disease Patients With IVS4 Mutation in Taiwan