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

NCT02987179 | Unknown

• 1 other identifier: RRI-16-002
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

ESRD; Sleep Apnea; Oxygen Deficiency

Outcome Measures

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.

  1 week

Study Arms (1)

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

Observational OTHER

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

ESRD Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Chronic hemodialysis patients

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Renal Research Institute: lead

Study Sites (1)

Renal Research Institute

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Kidney Failure, Chronic; Sleep Apnea Syndromes; Hypoxia

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2016
• First Posted: December 8, 2016
• Study Start: December 1, 2016
• Primary Completion: March 1, 2017
• Study Completion: December 1, 2017
• Last Updated: December 8, 2016

Record last verified: 2016-12

Locations

US (1)