Respiratory Restriction in Prader-Willi Syndrome (RESPIPWS)
Study of Respiratory Restriction in Patients With Prader-Willi Syndrome
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Verbania
-
Oggebbio, Verbania, Italy, 28824
- Istituto Auxologico Italiano IRCCS, Site Piancavallo
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Patients with Prader Will syndrome and BMI > 30 kg/m2
|
Spirometry for respiratory function and optoelectronic plethysmography for respiratory pattern during wakefulness
|
|
Control subjects with BMI < 25 kg/m2
|
Spirometry for respiratory function and optoelectronic plethysmography for respiratory pattern during wakefulness
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Rib cage contribution to ventilation
Time Frame: At enrollment
|
Percentage rib cage contribution to ventilation as measured by optoelectronic plethysmography
|
At enrollment
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Imprinting Disorders
- Neurologic Manifestations
- Nervous System Diseases
- Pathologic Processes
- Nutrition Disorders
- Genetic Diseases, Inborn
- Overnutrition
- Disease
- Neurobehavioral Manifestations
- Congenital Abnormalities
- Abnormalities, Multiple
- Overweight
- Intellectual Disability
- Obesity
- Chromosome Disorders
- Syndrome
- Prader-Willi Syndrome
Other Study ID Numbers
- 01C318
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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