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Sleep Patterns in Patients Affected by Lymphangioleiomiomatosis

NCT04577937 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2021-03-18

No results posted yet for this study

Summary

Lymphangioleiomyomatosis (LAM) is a rare and progressive pulmonary disease of unknown etiology that almost exclusively affects women. It is characterised by cystic radiological lung pattern and by the possible presence of angiomyolipomas in other sites or organs. Functionally LAM is associated with airway obstruction or restriction and progressive hypoxemia up to chronic respiratory failure.

There are no studies, so far, which have investigated whether during sleep these patients show changes in the sleep profile and gas exchange and if these changes are related to disease severity. Aim of the study, prospective and pilot, is to evaluate whether the physiological modification of respiratory mechanics during sleep is associated with polysomnographic alterations in LAM.

Conditions

  • Lymphangioleiomyomatosis
  • Sleep Disorder
  • Sleep Apnea Syndromes
  • Hypopnea Syndrome

Interventions

DIAGNOSTIC_TEST

LAM patients underwent PSG

Patients with confirmed diagnosis of LAM underwent a whole-night polysomnography. The presence of either acute or chronic respiratory failure or the use of long-term oxygen therapy are considered exclusion criteria

Sponsors & Collaborators

  • dr. Stefano Nava

    lead OTHER

Principal Investigators

  • Stefano Nava, MD-FERS · AOSP - Azienda Ospedaliero Universitaria Di Bologna

Study Design

Allocation
NA
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-30
Primary Completion
2021-07-08
Completion
2021-11-01

Countries

  • Italy

Study Locations

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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 NCT04577937 on ClinicalTrials.gov