Prader-Willi SyndromeRESPIPWSNCT06851351
Respiratory Restriction in Prader-Willi Syndrome
An observational study of Prader-Willi Syndrome, run by Istituto Auxologico Italiano at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Prader-Willi Syndrome
- What is being tested?
- Spirometry and optoelectronic plethysmography
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 16 Jan 2024to 5 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Patients with Prader Willi Syndrome and obesity
Who may be able to join
- Age 20-50 years
- Prader Willi Syndrome
- Body Mass Index > 30 kg/m2
- Age 20-50 years
- Body Mass Index < 25 kg/m2
Who cannot join
- Lack of signed consent form
- Control subjects
- Lack of signed consent form
Trial locations and contacts
1 site in 1 country.
Italy1 site
Istituto Auxologico Italiano IRCCS, Site Piancavallo
Oggebbio, Verbania, 28824
About this study
Official title: Study of Respiratory Restriction in Patients With 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.
Read the 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.
- Conditions
- Prader-Willi Syndrome
- Being tested
- Spirometry and optoelectronic plethysmography
- Keywords
- thoraco-abdominal volumes, lung volumes, optoelectronic plethysmography, respiratory manoeuvres, posture
- Medical subject headings
- Prader-Willi Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spirometry and optoelectronic plethysmographyDiagnostic test
Spirometry for respiratory function and optoelectronic plethysmography for respiratory pattern during wakefulness
| Study group | Role | What they receive |
|---|---|---|
| Patients with Prader Will syndrome and BMI > 30 kg/m2 | Not described Receives: Diagnostic Test: Spirometry and optoelectronic plethysmography | |
| Control subjects with BMI < 25 kg/m2 | Not described Receives: Diagnostic Test: Spirometry and optoelectronic plethysmography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rib cage contribution to ventilation
Percentage rib cage contribution to ventilation as measured by optoelectronic plethysmography
Measured: At enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2025
- Study start16 Jan 2024
- Primary completion5 Jul 2024
- Study completion5 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prader-Willi SyndromeStudies of the same condition, open and under way.
- More trials run by Istituto Auxologico ItalianoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Auxologico Italiano
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06851351
- Sponsor's protocol ID
- 01C318
- Acronym
- RESPIPWS
- Status last verified
- Feb 2025
- First submitted
- 24 Feb 2025
- Last updated
- 28 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Respiratory Restriction in Patients With Prader-Willi Syndrome
- ClinicalTrials.gov ID
- NCT06851351
- Acronym / sponsor ID
- RESPIPWS / 01C318
- Conditions
- Prader-Willi Syndrome
- Keywords
- thoraco-abdominal volumes, lung volumes, optoelectronic plethysmography, respiratory manoeuvres, posture
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Istituto Auxologico ItalianoUniversity, hospital or other
- Study start
- 16 Jan 2024 (actual)
- Primary completion
- 5 Jul 2024 (actual)
- Study completion
- 5 Jul 2024 (actual)
- First posted
- 28 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients with Prader Willi Syndrome and obesity
Key inclusion criteria (5 listed)
- Age 20-50 years
- Prader Willi Syndrome
- Body Mass Index > 30 kg/m2
- Age 20-50 years
- Body Mass Index < 25 kg/m2
Key exclusion criteria (3 listed)
- Lack of signed consent form
- Control subjects
- Lack of signed consent form
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spirometry and optoelectronic plethysmographySpirometry for respiratory function and optoelectronic plethysmography for respiratory pattern during wakefulness | Diagnostic test | Control subjects with BMI < 25 kg/m2, Patients with Prader Will syndrome and BMI > 30 kg/m2 |
Primary outcome
Rib cage contribution to ventilation
Time frame: At enrollment
Percentage rib cage contribution to ventilation as measured by optoelectronic plethysmography
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prader-Willi Syndrome, run by Istituto Auxologico Italiano at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rib cage contribution to ventilation (time frame: At enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2025.