ESRDNCT02987179
Identification of Desaturation Episodes by Means of Continuous Measurement of Oxygen Saturation During Hemodialysis
An observational study of ESRD and Sleep Apnea, run by Renal Research Institute at 1 site in United States.
Trial summary
The clinical diagnosis of sleep apnea is difficult among ESRD patients since the characteristic clinical features of sleep apnea may be absent and since sleep-related symptoms, such as fatigue and sleepiness, may be attributed to kidney failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ESRD, Sleep Apnea, Oxygen Deficiency
- What is being tested?
- Observational
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2016to Dec 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: Chronic hemodialysis patients
Who may be able to join
- Age ≥18 years and able to give written informed consent to the study
- On chronic hemodialysis for ≥ 90 days at time of enrollment
- Ability to read
- Consent to have video recording taken during study visit
Who cannot join
- Subjects with cognitive impairment to consent
- Sickle cell anemia
- Prescription of nasal oxygen
- Simultaneous participation in another clinical trial that may affect breathing frequency/patterns, blood oxygenation, sleep/wake cycle or other parameters related to the outcomes of interest to this study
- Use of a breathing device, e.g. CPAP
- Central venous catheter used as vascular access for hemodialysis
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- Artificial fingernails (may disturb the measurement of the WatchPAT)
- Use of one of the following medications: alpha blockers, short acting nitrates (less than 3 hours before the study).
- Permanent pacemaker
- Sustained non-sinus cardiac arrhythmias.
Trial locations and contacts
1 site in 1 country.
About this study
The clinical diagnosis of sleep apnea is difficult among ESRD patients since the characteristic clinical features of sleep apnea may be absent and since sleep-related symptoms, such as fatigue and sleepiness, may be attributed to kidney failure. However, the evaluation of patients with possible sleep apnea is the same among ESRD patients as in the general population.
- Conditions
- ESRD, Sleep Apnea, Oxygen Deficiency
- Being tested
- Observational
- Medical subject headings
- Kidney Failure, Chronic, Sleep Apnea Syndromes, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationalOther
Collect anthropomorphic, WatchPAT, Crit-line Monitor measurements as well as sleep questionnaires and video records
| Study group | Role | What they receive |
|---|---|---|
| ESRD Patients | The following inclusion criteria must be met for each subject.
* Age ≥18 years and able to give written informed consent to the study
* On chronic hemodialysis for ≥ 90 days at time of enrollment
* Ability to read
* Consent to have video recording taken during study visit Receives: Other: Observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identifying Intradialytis desaturation episodes
- To determine the sensitivity and specificity of the CLM for identifying intradialytic desaturation episodes, using the WatchPAT device as the reference method.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2016 (estimated)
- Study startDec 2016
- Primary completionMar 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ESRDStudies 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
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Renal Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02987179
- Sponsor's protocol ID
- RRI-16-002
- Status last verified
- Dec 2016
- First submitted
- 6 Dec 2016
- Last updated
- 8 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Desaturation Episodes by Means of Continuous Measurement of Oxygen Saturation During Hemodialysis
- ClinicalTrials.gov ID
- NCT02987179
- Acronym / sponsor ID
- RRI-16-002
- Conditions
- ESRD, Sleep Apnea, Oxygen Deficiency
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Renal Research InstituteUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- Mar 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 8 Dec 2016 (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 clinical diagnosis of sleep apnea is difficult among ESRD patients since the characteristic clinical features of sleep apnea may be absent and since sleep-related symptoms, such as fatigue and sleepiness, may be attributed to kidney failure. However, the evaluation of patients with possible sleep apnea is the same among ESRD patients as in the general population.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ESRD Patients | – | Other: ObservationalThe following inclusion criteria must be met for each subject. * Age ≥18 years and able to give written informed consent to the study * On chronic hemodialysis for ≥ 90 days at time of enrollment * Ability to read * Consent to have video recording taken during study visit |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Chronic hemodialysis patients
Key inclusion criteria (4 listed)
- Age ≥18 years and able to give written informed consent to the study
- On chronic hemodialysis for ≥ 90 days at time of enrollment
- Ability to read
- Consent to have video recording taken during study visit
Key exclusion criteria (10 listed)
- Subjects with cognitive impairment to consent
- Sickle cell anemia
- Prescription of nasal oxygen
- Simultaneous participation in another clinical trial that may affect breathing frequency/patterns, blood oxygenation, sleep/wake cycle or other parameters related to the outcomes of interest to this study
- Use of a breathing device, e.g. CPAP
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 |
|---|---|---|
| ObservationalCollect anthropomorphic, WatchPAT, Crit-line Monitor measurements as well as sleep questionnaires and video records | Other | ESRD Patients |
Primary outcome
Identifying Intradialytis desaturation episodes
Time frame: 1 week
• To determine the sensitivity and specificity of the CLM for identifying intradialytic desaturation episodes, using the WatchPAT device as the reference method.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 ESRD and Sleep Apnea, run by Renal Research Institute at 1 site in United States.
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 4 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 8 Dec 2016. 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 United States. 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?
Results are not available in the source record.
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?
Identifying Intradialytis desaturation episodes (time frame: 1 week). 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 8 Dec 2016.