Assessment of Health Effects of Air Purifier Interventions on Chronic Kidney Disease Patients

NCT06963372 | Completed

• 1 other identifier: 2022-03-023
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

This exploratory study investigates the impact of indoor air quality improvement via air purifiers on the health of chronic kidney disease (CKD) patients. A randomized, single-blind, crossover study with 24 CKD patients and 24 healthy controls was conducted at two hospitals. Participants used either a true filter or a sham filter in air purifiers for four weeks each, with a two-week washout period. True filters significantly reduced indoor PM2.5 levels compared to sham filters. Higher indoor PM2.5 levels were associated with increased cytokines (IL-1beta, IL-6, IL-8/CXCL8) and decreased hemoglobin, with ESR and PWV showing an increasing trend, particularly in CKD patients. True filters significantly reduced IL-1beta and IL-8/CXCL8 levels, with a borderline significant reduction in ABI. The study confirmed limited but notable effects of air purifiers on reducing PM2.5 and improving some health markers in CKD patients.

Conditions

Chronic Kidney Diseases; Particulate Matter

Outcome Measures

Primary Outcomes (6)

• IL-1beta in pg/mL

  Blood samples were collected to analyze cytokines.

  0 weeks, 4 weeks, 6 weeks, 10 weeks

• IL-6 in pg/mL

  Blood samples were collected to analyze cytokines.

  0 weeks, 4 weeks, 6 weeks, 10 weeks

• IL-8/CXCL8 in pg/mL

  Blood samples were collected to analyze cytokines.

  0 weeks, 4 weeks, 6 weeks, 10 weeks

• IL-10 in pg/mL

  Blood samples were collected to analyze cytokines.

  0 weeks, 4 weeks, 6 weeks, 10 weeks

• IFN-gamma in pg/mL

  Blood samples were collected to analyze cytokines.

  0 weeks, 4 weeks, 6 weeks, 10 weeks

• TNF-alpha in pg/mL

  Blood samples were collected to analyze cytokines.

  0 weeks, 4 weeks, 6 weeks, 10 weeks

Secondary Outcomes (4)

• Bood pressure (Systolic) in mmHg

  0 weeks, 4 weeks, 6 weeks, 10 weeks

• Bood pressure (Diastolic) in mmHg

  0 weeks, 4 weeks, 6 weeks, 10 weeks

• Pulse Wave Velocity in m/sec

  0 weeks, 4 weeks, 6 weeks, 10 weeks

• Ankle-Brachial Pressure Index

  0 weeks, 4 weeks, 6 weeks, 10 weeks

Study Arms (2)

Group A

EXPERIMENTAL

Group A used an air purifier equipped with a true filter for four weeks, followed by a two-week washout period, and then used an air purifier with a sham filter.

Device: True filter (4w) → Washout (2w) → Sham filter (4w)

Group B

EXPERIMENTAL

Group B used an air purifier equipped with a sham filter for four weeks, followed by a two-week washout period, and then used an air purifier with a true filter.

Device: Sham filter (4w) → Washout (2w) → True filter (4w)

Interventions

True filter (4w) → Washout (2w) → Sham filter (4w) DEVICE

Used a true filter for 4 weeks, followed by a 2-week washout, then used a sham filter for 4 weeks.

Group A

Sham filter (4w) → Washout (2w) → True filter (4w) DEVICE

Used a sham filter for 4 weeks, followed by a 2-week washout, then used a true filter for 4 weeks.

Group B

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient Group: Patients aged 20 years or older with stage 3 or higher chronic kidney disease (estimated glomerular filtration rate \[eGFR\] \<60 mL/min/1.73 m²).
• Control Group: Individuals aged 20 years or older who have not been told of any kidney function abnormalities based on blood tests within the past year and have never been diagnosed with chronic kidney disease. Baseline labs will be conducted, and only those with an eGFR ≥60 mL/min/1.73 m² will be enrolled. This group includes household members of the patient group or other healthy individuals.
• Individuals who are not currently using a household air purifier.
• Individuals who have consented to participate in the clinical study.

You may not qualify if:

• Patients with stage 5 chronic kidney disease.
• Individuals with a history of chronic obstructive pulmonary disease (COPD), asthma, allergy, cerebrovascular accident (CVA), malignancy (cancer), cardiovascular interventions, or those with an active infection.
• Individuals taking immunosuppressive medications.
• Patients with diabetes or hypertension whose blood sugar and blood pressure are uncontrolled (HbA1c \> 8%, office SBP \> 150 mmHg).

Sponsors & Collaborators

• Inha University Hospital: lead

Study Sites (1)

Inha University Hospital

Incheon, 22332, South Korea

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

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

Study Officials

• Hwan-Cheol Kim

  Inha University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: A randomized, single-blind, crossover study was conducted at two university hospitals in Seoul and Incheon, involving 24 CKD patients and 24 healthy controls. Participants underwent two repeated measures with each receiving either a true filter or a sham filter in air purifiers for four weeks, separated by a two-week washout period. The sequence of filter application was counterbalanced between two groups.

Study Record Dates

• First Submitted: August 22, 2024
• First Posted: May 9, 2025
• Study Start: April 11, 2022
• Primary Completion: November 1, 2022
• Study Completion: December 31, 2022
• Last Updated: May 9, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)