Sleep ApneaWITH-SASNCT01801592
Obstructive Sleep Apnoea in Patients With Intermittent Claudication
An observational study of Sleep Apnea, run by University Hospital, Angers at 1 site in France.
Trial summary
The main aim of this study is to determine how common undiagnosed obstructive sleep apnoea is in individuals with intermittent claudication. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Apnea
- How many people
- 140 participants
- Where
- 1 siteFrance
- Study dates
- 3 May 2013to 13 Oct 2017
- Phase
- Observational
- 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
Study population: men or women over 18 years old with an Intermitent claudication.
Who may be able to join
- Register to the social health insurance
- Referred for a walk test because of claudication
- Maximal walking ditance < 750m
- Older than 18 years old
- Able to understand the protocol of the study
Who cannot join
- Cardiac insufficiency already known, stage III or IV i.e. dyspnea at rest Unstable angina or myocardial infarction within the previous three months inclusion
- Severe reparatory disease already known
- Parkinson disease, hémiplégia ou paraplégia
- Does not want to participate to the protocol
- Pregnant women
- Adults to enhanced protection, deprived of their liberty by judicial or administrative authority, without consent hospitalized or admitted to a health facility or social purposes other than research
- Being in a period of exclusion from another biomedical study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevalence of Obstructive Sleep Apnoea in Patients With Intermittent Claudication
The main aim of this study is to determine how common undiagnosed obstructive sleep apnoea is in individuals with intermittent claudication.
Read the detailed description
In patients with peripheral artery disease (PAD), exercise induced limb ischemia (claudication) which limits walking capacity. Symptoms are due to pain at hip and/or buttock. Couple of origins may induce this pain such as vascular, cardiac, respiratory, musculoskeletal, neurologic, hematologic etc. The rate of associated respiratory pathology to patients with lower extremity artery disease (LEAD) is around 15%. The intolerance to walk could be link to an exercise hypoxia which appears with lower limb pain with or without associated dyspnea. The exercise hypoxemia becomes a diagnostic for an intermittent vascular claudication. Tests which are performed to diagnose an intermittent claudication are the Ankle to Brachial Systolic pressure Index (ABI), the echo-Doppler of lower limb arteries and the walking test on a treadmill associated to a measurement of the distal and chest transcutaneous oxygen pressure (tcpO2).
Thus, the purpose of the present research is to determine the prevalence of obstructive sleep apnoea in patient with PAD.
- Conditions
- Sleep Apnea
- Keywords
- OBSTRUCTIVE SLEEP APNOEA, INTERMITTENT CLAUDICATION, Respiratory disease, Peripheral artery disease
- Medical subject headings
- Sleep Apnea Syndromes, Sleep Apnea, Obstructive, Intermittent Claudication, Respiration Disorders, Peripheral Arterial Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of an Apnea hyponea index > 15
Recording of sleep with the RESMED (Apnealink) system
Measured: up to 2 months after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2013 (estimated)
- Study start3 May 2013
- Primary completion13 Oct 2017
- Study completion13 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep ApneaStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Guillaume Mahe, MD; PhD, Principal investigator, University Hospital in Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01801592
- Sponsor's protocol ID
- 2012-A01124-39
- Acronym
- WITH-SAS
- Status last verified
- Feb 2016
- First submitted
- 18 Feb 2013
- Last updated
- 1 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Obstructive Sleep Apnoea in Patients With Intermittent Claudication
- ClinicalTrials.gov ID
- NCT01801592
- Acronym / sponsor ID
- WITH-SAS / 2012-A01124-39
- Conditions
- Sleep Apnea
- Keywords
- OBSTRUCTIVE SLEEP APNOEA, INTERMITTENT CLAUDICATION, Respiratory disease, Peripheral artery disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 3 May 2013 (actual)
- Primary completion
- 13 Oct 2017 (actual)
- Study completion
- 13 Oct 2017 (actual)
- First posted
- 1 Mar 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.
The main aim of this study is to determine how common undiagnosed obstructive sleep apnoea is in individuals with intermittent claudication.
Detailed description
In patients with peripheral artery disease (PAD), exercise induced limb ischemia (claudication) which limits walking capacity. Symptoms are due to pain at hip and/or buttock. Couple of origins may induce this pain such as vascular, cardiac, respiratory, musculoskeletal, neurologic, hematologic etc. The rate of associated respiratory pathology to patients with lower extremity artery disease (LEAD) is around 15%. The intolerance to walk could be link to an exercise hypoxia which appears with lower limb pain with or without associated dyspnea. The exercise hypoxemia becomes a diagnostic for an intermittent vascular claudication. Tests which are performed to diagnose an intermittent claudication are the Ankle to Brachial Systolic pressure Index (ABI), the echo-Doppler of lower limb arteries and the walking test on a treadmill associated to a measurement of the distal and chest transcutaneous oxygen pressure (tcpO2).
Thus, the purpose of the present research is to determine the prevalence of obstructive sleep apnoea in patient with PAD.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- men or women over 18 years old with an Intermitent claudication.
Key inclusion criteria (5 listed)
- Register to the social health insurance
- Referred for a walk test because of claudication
- Maximal walking ditance < 750m
- Older than 18 years old
- Able to understand the protocol of the study
Key exclusion criteria (7 listed)
- Cardiac insufficiency already known, stage III or IV i.e. dyspnea at rest Unstable angina or myocardial infarction within the previous three months inclusion
- Severe reparatory disease already known
- Parkinson disease, hémiplégia ou paraplégia
- Does not want to participate to the protocol
- Pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of an Apnea hyponea index > 15
Time frame: up to 2 months after inclusion
Recording of sleep with the RESMED (Apnealink) system
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 1 Nov 2017.
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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.
Guillaume Mahe, MD; PhD principal investigator
University Hospital in Angers
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Apnea, run by University Hospital, Angers at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. 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 1 Nov 2017. 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 France. 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 of an Apnea hyponea index > 15 (time frame: up to 2 months after inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Nov 2017.