Effects of Railway Vibration on Sleep and Disease

NCT06260254 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2025-03-13

No results posted yet for this study

Summary

This study will investigate the biological mechanisms linking sleep disruption by vibration and noise, and the development of cardiometabolic disease. In a laboratory sleep study, the investigators will play railway vibration of different levels during the night. The investigators will also measure objective sleep quality and quantity, cognitive performance across multiple domains, self-reported sleep and wellbeing outcomes, and blood samples. Blood samples will be analyzed to identify metabolic changes and indicators of diabetes risk in different nights. Identifying biomarkers that are impacted by sleep fragmentation will establish the currently unclear pathways by which railway vibration exposure at night can lead to the development of diseases in the long term, especially metabolic disorders including diabetes.

Conditions

  • Noise Exposure
  • Sleep Disturbance
  • Sleep Hygiene
  • Metabolic Disturbance
  • Cognitive Change
  • Glucose Metabolism Disorders (Including Diabetes Mellitus)
  • Vibration; Exposure

Interventions

RADIATION

Railway noise

Low level railway noise, not exceeding 50 dB LAF,max. Thirty six single railway noise events.

RADIATION

Low level railway vibration

36 single railway noise events at 0.5 mm/s, varying from 11.5 s to 56.9 s in duration. Vibration always occurs concurrently with the noise exposure.

RADIATION

Intermediate level railway vibration

36 single railway noise events at 0.7 mm/s, varying from 11.5 s to 56.9 s in duration. Vibration always occurs concurrently with the noise exposure.

RADIATION

High level railway vibration

36 single railway noise events at 0.9 mm/s, varying from 11.5 s to 56.9 s in duration. Vibration always occurs concurrently with the noise exposure.

Sponsors & Collaborators

Principal Investigators

  • Michael G Smith, PhD · Göteborg University

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
30 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-02-05
Primary Completion
2024-06-14
Completion
2024-10-31

Countries

  • Sweden

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06260254 on ClinicalTrials.gov