Respiratory Restriction in Prader-Willi Syndrome

The main aim of this study is therefore to evaluate the impact of Prader Willi Syndrome (PWS) on lung and thoracoabdominal volumes, respiratory muscle strength and awake ventilatory pattern, and to quantify and localize the PWS-induced respiratory restriction.

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Key information

Conditions

Prader-Willi Syndrome Abnormalities, Multiple Chromosome Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Imprinting Disorders Intellectual Disability Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Istituto Auxologico Italiano IRCCS, Site Piancavallo

Oggebbio, Verbania, 28824, Italy

About this study

The aim is to study lung function in obese PWS patients using both volitional (spirometry, nitrogen wash-out, and maximal pressure measurements (MIP and MEP)) and non-volitional (awake ventilatory pattern by opto-electron plethysmography) tests, both in sitting and supine positions.

Spirometry, nitrogen wash-out, and MIP and MEP measurements are comprehensive assessments, while optoelectronic plethysmography allows restriction location through accurate measurement of thoracoabdominal volumes.

The results of the study could provide useful information about the calculation of the volumes enclosed by the grid of markers (in particular, the volume of the rib cage, which reflects the action of the intercostal muscles, the volume of the abdomen, which reflects the action of the diaphragm in the inspiratory phase and of the abdominal muscles during exhalation and their sum, which represents the total variation of the thoraco-abdominal wall. All these finds could be useful for respiratory rehabilitation protocols for obese PWS patients.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Patients with Prader Willi Syndrome

Inclusion criteria

Age 20-50 years
Prader Willi Syndrome
Body Mass Index > 30 kg/m2

Exclusion criteria

Lack of signed consent form

Control subjects

Inclusion criteria

Age 20-50 years
Body Mass Index < 25 kg/m2

Exclusion criteria

Lack of signed consent form

Treatment and study plan

Spirometry and optoelectronic plethysmography

Diagnostic Test

Spirometry for respiratory function and optoelectronic plethysmography for respiratory pattern during wakefulness

Primary outcomes

Rib cage contribution to ventilation

Time frame: At enrollment

Percentage rib cage contribution to ventilation as measured by optoelectronic plethysmography

Sponsors and collaborators

Lead sponsor

Istituto Auxologico Italiano

Other

Registry information

Official study title

Study of Respiratory Restriction in Patients With Prader-Willi Syndrome

Acronym: RESPIPWS

Important dates

Study start: 2024
Primary completion: 2024
Study completion: 2024
First posted: Feb 28, 2025
Registry last updated: Feb 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed