Effect of CPAP Therapy on Molecular Breath Patterns in Pa... | NCT04638933

Studies
Effect of CPAP Therapy on Molecular Breath Patterns in Patients With OSA

NCT04638933

Sponsor

Malcolm Kohler

Status

Completed

Last Update Posted

Nov 29, 2023Actual

Enrollment

53Actual

Phase

Not provided

Conditions

Obstructive Sleep Apnea

Interventions

No intervention

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 6, 2020Actual

Primary Completion Date

Jan 31, 2023Actual

Completion Date

Jan 31, 2023Actual

First Submitted Date

Nov 16, 2020

First Submission Date that Met QC Criteria

Nov 16, 2020

First Posted Date

Nov 20, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 28, 2023

Last Update Posted Date

Nov 29, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Determination of changes in molecular breath patterns in OSA patients, naïve for OSA treatment before and after one month of CPAP therapy by untargeted, secondary electrospray ionisation-high resolution mass spectrometry (SESI-HRMS). Furthermore, breath patterns will be assessed for correlation and association to clinical outcomes such as change in OSA severity, sleepiness, and blood pressure.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

53Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
OSA patients		Patients with proven OSA (apnea-hypopnea index ≥20/h, ESS >10, age ≥18 years) and initiation of CPAP treatment	Other: No intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
No intervention	Other	No intervention	OSA patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Exhaled breath pattern	Change in exhaled breath pattern in response to one month of CPAP treatment	twice during 1 month

Secondary Outcomes

Measure	Description	Time Frame
OSA severity parameter	Correlation of breath print with changes in OSA severity parameters on CPAP (e.g. AHI, ODI)	twice during 1 month
Vital signs	Correlation of breath print with changes in blood pressure and heart rate

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Recently diagnosed OSA (AHI ≥20/h)
Patient is willing to start CPAP therapy
ESS > 10 points
18 years or above

Exclusion Criteria:

Moribund or severe disease prohibiting protocol adherence
Use of oxygen therapy or home ventilation
Physical or intellectual impairment precluding informed consent or protocol adherence
Known malignancy, acute pulmonary disease, drug or alcohol abuse, known active inflammatory diseases (e.g. autoimmune disease), relevant congenital defects e.g. amino acid metabolism defect, relevant endocrinological disease, renal failure (GFR < 15 mL/min)
Pregnant patients

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with proven OSA (apnea-hypopnea index ≥20/h, ESS >10, age ≥18 years) and initiation of CPAP treatment

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Zurich		Zurich		8091	Switzerland

Condition Browse Module

MeSH Terms

ID	Term
D020181	Sleep Apnea, Obstructive

Ancestor Terms

ID	Term
D012891	Sleep Apnea Syndromes
D001049	Apnea
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided