Fabry DiseaseNCT01947634
Sleepiness and Sleep-disordered Breathing in Fabry Disease. A Prospective Cohort Study.
A study testing ResMed Apnea Link plus in people with Fabry Disease, run by University of Zurich at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fabry Disease
- What is being tested?
- ResMed Apnea Link plus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteSwitzerland
- Study dates
- Sep 2013to Feb 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Inclusion criteria: Established diagnosis of Fabry disease, who
- are 18 years or above
- have signed informed consent.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Zurich, Division of Internal Medicine
Zurich, Canton of Zurich, 8091
About this study
Official title: Cross-sectional Study on the Incidence of Sleepiness and Sleep-disordered Breathing in Patients With Fabry Disease
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.
Read the detailed 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 (ApneaLink™ 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 ApneaLink™ 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.
- Conditions
- Fabry Disease
- Being tested
- ResMed Apnea Link plus
- Medical subject headings
- Fabry Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ResMed Apnea Link plusOther
Overnight respiratory polygraphy to detect sleep-related breathing disorders is performed in Fabry patients
| Study group | Role | What they receive |
|---|---|---|
| ResMed Apnea Link plus | Experimental | Overnight respiratory polygraphy is performed in Fabry patients Receives: Other: ResMed Apnea Link plus |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2013 (estimated)
- Study startSep 2013
- Primary completionJan 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fabry DiseaseStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel Franzen, MD, Principal investigator, University Hospital Zurich, Division of Internal Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01947634
- Sponsor's protocol ID
- SleepFabry
- Status last verified
- Feb 2015
- First submitted
- 12 Sep 2013
- Last updated
- 3 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Franzen D, Gerard N, Bratton DJ, Wons A, Gaisl T, Sievi NA, Clarenbach CF, Kohler M, Krayenbuhl PA. Prevalence and Risk Factors of Sleep Disordered Breathing in Fabry disease: A Prospective Cohort Study. Medicine (Baltimore). 2015 Dec;94(52):e2413. doi: 10.1097/MD.0000000000002413.
PubMed 26717401
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross-sectional Study on the Incidence of Sleepiness and Sleep-disordered Breathing in Patients With Fabry Disease
- ClinicalTrials.gov ID
- NCT01947634
- Acronym / sponsor ID
- SleepFabry
- Conditions
- Fabry Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Jan 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 20 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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 (ApneaLink™ 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 ApneaLink™ 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ResMed Apnea Link plus | Experimental | Other: ResMed Apnea Link plusOvernight respiratory polygraphy is performed in Fabry patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ResMed Apnea Link plusOvernight respiratory polygraphy to detect sleep-related breathing disorders is performed in Fabry patients | Other | ResMed Apnea Link plus |
Primary outcome
Prevalence and type of sleep-related breathing disorder in Fabry patients.
Time frame: Day 1
Prevalence and type of sleep-related breathing disorder in Fabry patients measured with overnight ambulatory respiratory polygraphy.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2015.
- Derived from this study: PubMed 26717401Franzen D, Gerard N, Bratton DJ, Wons A, Gaisl T, Sievi NA, Clarenbach CF, Kohler M, Krayenbuhl PA. Prevalence and Risk Factors of Sleep Disordered Breathing in Fabry disease: A Prospective Cohort Study. Medicine (Baltimore). 2015 Dec;94(52):e2413. doi: 10.1097/MD.0000000000002413.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Franzen, MD principal investigator
University Hospital Zurich, Division of Internal Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ResMed Apnea Link plus in people with Fabry Disease, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence and type of sleep-related breathing disorder in Fabry patients. (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01947634, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2015.