Obesity in Sleep Medicine - Focusing on OHS Phenotypes

September 29, 2020 updated by: Wissenschaftliches Institut Bethanien e.V
This study focuses on a comprehensive examination of obese patients with sleep-related breathing disorders including patients with OSA, sleep hypoventilation and OHS. The aim of this study is to (1) evaluate characteristics of and differences between severity levels of obesity-related breathing disorders, (2) discuss pathophysiological variables associated with hypoventilation during sleep or at daytime and (3) find functional parameters indicating sleep hypoventilation.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
82

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Nordrhein-Westfalen
      • Solingen, Nordrhein-Westfalen, Germany, 42699
        • Institut für Pneumologie an der Universität zu Köln / Wissenschaftliches Institut Bethanien für Pneumologie e.V.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Obese patient routinely admitted to sleep lab

Description

Inclusion Criteria:

  • Age ≥18 years
  • BMI ≥ 30 kg/m²
  • Indication for sleep lab admission or indication for BiLevel or non-invasive ventilation therapy initiation due to existing hypoventilation/OHS

Exclusion Criteria:

  • Age <18 years
  • Pregnancy, Lactation
  • Any medical, psychological or other condition impairing the patient's ability to provide informed consent.
  • Missing informed consent
  • Participation in another clinical study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
OSA
Obstructive Sleep Apnea as confirmed by full-night attended in-lab polysomnography showing an apnea-hypopnea index of >=15 per hour or, alternatively, an apnea-hypopnea index >=5 with excessive daytime sleepiness as defined by an Epworth Sleepiness Scale score >9.
Diagnostic test: Sleep Study
Full-night attended in-lab polysomnography with accompanying transcutaneous capnometry
Diagnostic test: Pulmonary Function Test
Bodyplethysmographic assessment
Diagnostic test: Hypercapnic ventilatory response
Measurement of hypercapnic ventilatory response based on the method described by Read in 1967, using a rebreathing bag
Diagnostic test: Cardiopulmonary Exercise Test
Symptom-limited cardiopulmonary exercise test with a ramp protocol according to the ATS/ACCP and ERS recommendations
OSA+SH
Obstructive Sleep Apnea as confirmed by full-night attended in-lab polysomnography showing an apnea-hypopnea index of >=15 per hour or, alternatively, an apnea-hypopnea index >=5 with excessive daytime sleepiness as defined by an Epworth Sleepiness Scale score >9. Furthermore, co-existing hypoventilation during sleep, defined by the presence of intermittent hypercapnia as measured by transcutaneous capnometry and arterialized capillary blood gas analysis.
Diagnostic test: Sleep Study
Full-night attended in-lab polysomnography with accompanying transcutaneous capnometry
Diagnostic test: Pulmonary Function Test
Bodyplethysmographic assessment
Diagnostic test: Hypercapnic ventilatory response
Measurement of hypercapnic ventilatory response based on the method described by Read in 1967, using a rebreathing bag
Diagnostic test: Cardiopulmonary Exercise Test
Symptom-limited cardiopulmonary exercise test with a ramp protocol according to the ATS/ACCP and ERS recommendations
OHS
Obstructive Sleep Apnea as confirmed by full-night attended in-lab polysomnography showing an apnea-hypopnea index of >=15 per hour or, alternatively, an apnea-hypopnea index >=5 with excessive daytime sleepiness as defined by an Epworth Sleepiness Scale score >9. Furthermore, co-existing hypoventilation during wakefulness, defined by a PCO2>45mmHg as measured by arterialized capillary blood gas analysis.
Diagnostic test: Sleep Study
Full-night attended in-lab polysomnography with accompanying transcutaneous capnometry
Diagnostic test: Pulmonary Function Test
Bodyplethysmographic assessment
Diagnostic test: Hypercapnic ventilatory response
Measurement of hypercapnic ventilatory response based on the method described by Read in 1967, using a rebreathing bag
Diagnostic test: Cardiopulmonary Exercise Test
Symptom-limited cardiopulmonary exercise test with a ramp protocol according to the ATS/ACCP and ERS recommendations

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Hypercapnic ventilatory response
Time Frame: Within 48 hours of sleep lab admission
Within 48 hours of sleep lab admission

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Wissenschaftliches Institut Bethanien e.V

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Philips Respironics

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Winfried J Randerath, Prof. Dr., Chief Physician

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 24, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 10, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 10, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 25, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 29, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 30, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 30, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 29, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • WI_137/2013

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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