Obesity Hypoventilation SyndromeNCT01964339
Obesity Hypoventilation Syndrome Prevalence Study
An observational study of Obesity Hypoventilation Syndrome, run by Philips Respironics at 1 site in United States.
Trial summary
This is an observational study to characterize the prevalence of Obesity Hypoventilation Syndrome in patients referred to the sleep lab. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Obesity Hypoventilation Syndrome
- What is being tested?
- BMI greater than or equal to 30kg/m2 scheduled for PSG. Undergo blood draw (venous blood gas and metabolic panel) and data collection from PSG study. and BMI greater than or equal to 30kg/m2 scheduled for PSG. Undergo blood draw (arterial blood gas and metabolic panel) and data collection from PSG study.
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Oct 2013to 21 May 2014
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: People with a BMI greater than or equal to 30kg/m2 scheduled for a routine polysomnograpy (PSG) test. Participants will be recruited from pulmonology clinics or referred to the sleep lab via hospital admissions.
Who may be able to join
- Greater than or equal to 21 yrs. of age
- Referred to sleep lab for diagnostic PSG, initial titration PSG or split night PSG as routine clinical care
- BMI greater than or equal to 30kg/m2
Who cannot join
- Acutely ill or medically unstable to participate per PI
- Current positive airway pressure(PAP therapy)users
- Medical History of Chronic Obstructive Pulmonary Disease(COPD)
- Incapable of providing own informed consent
- BMI less than 30kg/m2
Trial locations and contacts
1 site in 1 country.
United States1 site
Ochsner Baptist Medical Center
New Orleans, Louisiana, 70115
About this study
This is an observational study to characterize the prevalence of Obesity Hypoventilation Syndrome in patients referred to the sleep lab.
- Conditions
- Obesity Hypoventilation Syndrome
- Being tested
- BMI greater than or equal to 30kg/m2 scheduled for PSG. Undergo blood draw (venous blood gas and metabolic panel) and data collection from PSG study., BMI greater than or equal to 30kg/m2 scheduled for PSG. Undergo blood draw (arterial blood gas and metabolic panel) and data collection from PSG study.
- Medical subject headings
- Obesity Hypoventilation Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMI greater than or equal to 30kg/m2 scheduled for PSG. Undergo blood draw (venous blood gas and metabolic panel) and data collection from PSG study.Other
Venous blood gas, basic metabolic panel, PSG variable data collection.
BMI greater than or equal to 30kg/m2 scheduled for PSG. Undergo blood draw (arterial blood gas and metabolic panel) and data collection from PSG study.Other
Arterial blood gas, basic metabolic panel, PSG variable data collection
| Study group | Role | What they receive |
|---|---|---|
| BMI greater than or equal to 30kg/m2 -venous | BMI greater than or equal to 30kg/m2 scheduled for PSG as part of routine clinical care. Participants will undergo blood draw (venous blood gas and metabolic panel) and data collection from PSG study. Receives: Other: BMI greater than or equal to 30kg/m2 scheduled for PSG. Undergo blood draw (venous blood gas and metabolic panel) and data collection from PSG study. | |
| BMI greater than or equal to 30kg/m2 - arterial | BMI greater than or equal to 30kg/m2 scheduled for PSG as part of routine clinical care. Participants will undergo blood draw (arterial blood gas and metabolic panel) and data collection from PSG study. Receives: Other: BMI greater than or equal to 30kg/m2 scheduled for PSG. Undergo blood draw (arterial blood gas and metabolic panel) and data collection from PSG study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline venous blood draw
The study involves a venipuncture and data collection at the time of sleep study. Data collection will be correlated to blood draw results.
Measured: single blood draw
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2013 (estimated)
- Study start9 Oct 2013
- Primary completion21 May 2014
- Study completion21 May 2014
Why it stopped: This study was stopped due to low recruitment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity Hypoventilation SyndromeStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philips Respironics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01964339
- Sponsor's protocol ID
- HRC-1240-OHSPREV-MS
- Status last verified
- Dec 2018
- First submitted
- 14 Oct 2013
- Last updated
- 11 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Obesity Hypoventilation Syndrome Prevalence Study
- ClinicalTrials.gov ID
- NCT01964339
- Acronym / sponsor ID
- HRC-1240-OHSPREV-MS
- Conditions
- Obesity Hypoventilation Syndrome
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: This study was stopped due to low recruitment.
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Philips RespironicsIndustry (pharma, biotech, devices)
- Study start
- 9 Oct 2013 (actual)
- Primary completion
- 21 May 2014 (actual)
- Study completion
- 21 May 2014 (actual)
- First posted
- 17 Oct 2013 (estimated)
- 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.
This is an observational study to characterize the prevalence of Obesity Hypoventilation Syndrome in patients referred to the sleep lab.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BMI greater than or equal to 30kg/m2 -venous | – | Other: BMI greater than or equal to 30kg/m2 scheduled for PSG. Undergo blood draw (venous blood gas and metabolic panel) and data collection from PSG study.BMI greater than or equal to 30kg/m2 scheduled for PSG as part of routine clinical care. Participants will undergo blood draw (venous blood gas and metabolic panel) and data collection from PSG study. |
| BMI greater than or equal to 30kg/m2 - arterial | – | Other: BMI greater than or equal to 30kg/m2 scheduled for PSG. Undergo blood draw (arterial blood gas and metabolic panel) and data collection from PSG study.BMI greater than or equal to 30kg/m2 scheduled for PSG as part of routine clinical care. Participants will undergo blood draw (arterial blood gas and metabolic panel) and data collection from PSG study. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- People with a BMI greater than or equal to 30kg/m2 scheduled for a routine polysomnograpy (PSG) test. Participants will be recruited from pulmonology clinics or referred to the sleep lab via hospital admissions.
Key inclusion criteria (3 listed)
- Greater than or equal to 21 yrs. of age
- Referred to sleep lab for diagnostic PSG, initial titration PSG or split night PSG as routine clinical care
- BMI greater than or equal to 30kg/m2
Key exclusion criteria (5 listed)
- Acutely ill or medically unstable to participate per PI
- Current positive airway pressure(PAP therapy)users
- Medical History of Chronic Obstructive Pulmonary Disease(COPD)
- Incapable of providing own informed consent
- BMI less than 30kg/m2
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 |
|---|---|---|
| BMI greater than or equal to 30kg/m2 scheduled for PSG. Undergo blood draw (venous blood gas and metabolic panel) and data collection from PSG study.Venous blood gas, basic metabolic panel, PSG variable data collection. | Other | BMI greater than or equal to 30kg/m2 -venous |
| BMI greater than or equal to 30kg/m2 scheduled for PSG. Undergo blood draw (arterial blood gas and metabolic panel) and data collection from PSG study.Arterial blood gas, basic metabolic panel, PSG variable data collection | Other | BMI greater than or equal to 30kg/m2 - arterial |
Primary outcome
Baseline venous blood draw
Time frame: single blood draw
The study involves a venipuncture and data collection at the time of sleep study. Data collection will be correlated to blood draw results.
Results and safety
The study was stopped early (reason given: This study was stopped due to low recruitment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2018.
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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 Obesity Hypoventilation Syndrome, run by Philips Respironics at 1 site in United States.
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 3 inclusion and 5 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: stopped early, as of the sponsor's last update on 11 Dec 2018. 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 United States. 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 was stopped early (reason given: This study was stopped due to low recruitment.). Results are not available in the source record.
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?
Baseline venous blood draw (time frame: single blood draw). 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 11 Dec 2018.