NCT06851351

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 16, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 5, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 5, 2024

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 24, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 28, 2025

Completed
Last Updated

February 28, 2025

Status Verified

February 1, 2025

Enrollment Period

6 months

First QC Date

February 24, 2025

Last Update Submit

February 24, 2025

Conditions

Prader-Willi Syndrome

Keywords

thoraco-abdominal volumeslung volumesoptoelectronic plethysmographyrespiratory manoeuvresposture

Outcome Measures

Primary Outcomes (1)

  • Rib cage contribution to ventilation

    Percentage rib cage contribution to ventilation as measured by optoelectronic plethysmography

    At enrollment

Study Arms (2)

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

Diagnostic Test: Spirometry and optoelectronic plethysmography

Control subjects with BMI < 25 kg/m2

Diagnostic Test: Spirometry and optoelectronic plethysmography

Interventions

Spirometry and optoelectronic plethysmographyDIAGNOSTIC_TEST

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

Control subjects with BMI < 25 kg/m2Patients with Prader Will syndrome and BMI > 30 kg/m2

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients with Prader Willi Syndrome and obesity

You may qualify if:

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

You may not qualify if:

  • Lack of signed consent form
  • Control subjects
  • Age 20-50 years
  • Body Mass Index \< 25 kg/m2
  • Lack of signed consent form

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istituto Auxologico Italiano IRCCS, Site Piancavallo

Oggebbio, Verbania, 28824, Italy

Location

MeSH Terms

Conditions

Prader-Willi Syndrome

Interventions

Spirometry

Condition Hierarchy (Ancestors)

Intellectual DisabilityNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesAbnormalities, MultipleCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesChromosome DisordersGenetic Diseases, InbornImprinting DisordersObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Respiratory Function TestsDiagnostic Techniques, Respiratory SystemDiagnostic Techniques and ProceduresDiagnosis

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 24, 2025

First Posted

February 28, 2025

Study Start

January 16, 2024

Primary Completion

July 5, 2024

Study Completion

July 5, 2024

Last Updated

February 28, 2025

Record last verified: 2025-02

Locations

IT(1)