Sleep Patterns in Patients Affected by Lymphangioleiomiomatosis

NCT04577937 | Unknown

• 1 other identifier: 270/2016/O/Oss/AOUB
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (5)

• prevalence of sleep disorders in LAM

  Aim of the project is to assess the presence of sleep disorders (oxygen destaruration during sleep and/or sleep apnea or hypopnea) in patients affected by LAM.

  1 year

• correlation between sleep-related disorders and LAM severity measured by spirometry

  Another aim of the project is to stratify the presence of sleep-related disorders (oxygen desaturation during sleep, sleep apnea or hypopnea) according to the severity of LAM measured through functional impairment. By spirometry performed at the time of PSG the study population will be divided in: subjects with obstructive impairment; subjects with restrictive abnormality and subjects with no alterations.

  1 year

• correlation between sleep-related disorders and LAM severity measured by annual decline of forced-expiratory volume at the first second (FEV1)

  Another aim of the project is to stratify the presence of sleep-related disorders (oxygen desaturation during sleep, sleep apnea or hypopnea) according to the severity of LAM measured by annual decline of forced-expiratory volume at the first second (FEV1), expressed in ml/year. Annual decline of FEV1 will be measured subtracting the FEV1 value (ml) at the time of PSG test to the FEV1 value (ml) at the time of diagnosis and then, dividing it by disease duration in years.

  1 year

• correlation between sleep-related disorders and LAM severity measured by arterial blood gas exchange

  Another aim of the project is to stratify the presence of sleep-related disorders (oxygen desaturation during sleep, sleep apnea or hypopnea) according to the severity of LAM measured through arterial blood gas exchanges values: partial pressure of oxygen (PaO2 - mmHg), partial pressure of carbon dioxide (PaCO2 - mmHg), oxygen saturation (SatO2, %).

  1 year

• correlation between sleep-related disorders and clincal parameters

  Moreover, another aim is to assess the distribution of sleep disorders (oxygen desaturation during sleep, sleep apnea or hypopnea) according to age, sex, body mass index (BMI), comorbidities in patients affected by LAM. BMI will be calculated using height (mt) and weight (Kg) at the time of PSG and expressed in Kg/m\^2.

  1 year

Study Arms (1)

PSG in LAM patients

EXPERIMENTAL

Patients affected by LAM underwent whole-night PSG

Diagnostic Test: LAM patients underwent PSG

Interventions

LAM patients underwent PSG DIAGNOSTIC_TEST

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

PSG in LAM patients

Eligibility Criteria

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

You may qualify if:

• confirmed diagnosis of LAM according to current guidelines
• sign of informed consent to participate

You may not qualify if:

• the presence of either acute or chronic respiratory failure
• the use of long-term oxygen therapy

Sponsors & Collaborators

• dr. Stefano Nava: lead

Study Sites (1)

Azienda Ospedaliero-Universitaria di Bologna

Bologna, 40138, Italy

RECRUITING

MeSH Terms

Conditions

Lymphangioleiomyomatosis; Sleep Wake Disorders; Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Lymphangiomyoma; Neoplasm, Lymphatic Tissue; Neoplasms by Histologic Type; Neoplasms; Perivascular Epithelioid Cell Neoplasms; Neoplasms, Connective and Soft Tissue; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias

Study Officials

• Stefano Nava, MD-FERS

  AOSP - Azienda Ospedaliero Universitaria Di Bologna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stefano Nava, MD-FERS

CONTACT

00390512143253; stefano.nava@aosp.bo.it

Irene Prediletto, MD-PhD

CONTACT

00390512143253; irene.prediletto@aosp.bo.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor Stefano Nava, MD-FERS

Model Details: cohort study, pilot

Study Record Dates

• First Submitted: June 30, 2020
• First Posted: October 8, 2020
• Study Start: June 30, 2020
• Primary Completion: July 8, 2021
• Study Completion: November 1, 2021
• Last Updated: March 18, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)