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Status unknownNCT02987179Updated Dec 8, 2016

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

An observational study in ESRD, Sleep Apnea and Oxygen Deficiency, sponsored by Renal Research Institute. Status unknown at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-12-08.

Sponsored by Renal Research Institute · Observational

The sponsor has not verified this record recently (last verified Dec 2016), so the status shown — last known as Enrolling by invitation — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
30
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • ESRD
  • Sleep Apnea
  • Oxygen Deficiency

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03

In context

Hypoxia

1,231 studies on the registry are indexed under Hypoxia; 241 are open to participants now.

This study's planned enrollment of 30 is below the median of 67 across 335 observational studies indexed under Hypoxia.

Browse Hypoxia studies →

Lead sponsor

Renal Research Institute is the lead sponsor of 18 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Chronic hemodialysis patients

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

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.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
30 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

    Other: Observational

Interventions

  • OtherObservational

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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1 week

07

Study locations

1 site
  • Renal Research Institute
    New York, New York 10065, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 8, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02987179
Lead sponsor
Renal Research Institute
Responsible party
Sponsor
First posted
Dec 8, 2016
Start date
Dec 2016
Primary completion
Mar 2017 (estimated)
Completion
Dec 2017 (estimated)
Last update
Dec 8, 2016

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2016. You cannot join it, but the record below documents what was studied.

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