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Identification of Desaturation Episodes by Means of Continuous Measurement of Oxygen Saturation During Hemodialysis

Identification of Desaturation Episodes by Means of Continuous Measurement of Oxygen Saturation During Hemodialysis

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02987179
Enrollment
30
Registered
2016-12-08
Start date
2016-12-31
Completion date
2017-12-31
Last updated
2016-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ESRD, Oxygen Deficiency, Sleep Apnea

Brief 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. However, the evaluation of patients with possible sleep apnea is the same among ESRD patients as in the general population.

Interventions

OTHERObservational

Collect anthropomorphic, WatchPAT, Crit-line Monitor measurements as well as sleep questionnaires and video records

Sponsors

Renal Research Institute
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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 * 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.

Design outcomes

Primary

MeasureTime frameDescription
Identifying Intradialytis desaturation episodes1 week• To determine the sensitivity and specificity of the CLM for identifying intradialytic desaturation episodes, using the WatchPAT device as the reference method.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026