Respiratory Restriction in Prader-Willi Syndrome (RESPIPWS)

Istituto Auxologico Italiano

Status: Completed

Conditions: Prader-Willi Syndrome

Treatments: Diagnostic Test: Spirometry and optoelectronic plethysmography

Study type: Observational

Funder types: Other

Identifiers

NCT06851351

01C318

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 30 patients

Sex: All

Ages: 20 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

30 participants in 2 patient groups

Patients with Prader Will syndrome and BMI > 30 kg/m2

Treatment:

Diagnostic Test: Spirometry and optoelectronic plethysmography

Control subjects with BMI < 25 kg/m2

Treatment:

Diagnostic Test: Spirometry and optoelectronic plethysmography