Obesity Hypoventilation SyndromeNCT03449641
PAP Therapy in Patients With Obesity Hypoventilation Syndrome
A study testing Positive airway pressure (PAP) in people with Obesity Hypoventilation Syndrome, run by University of Crete.
Trial summary
The role of different levels of compliance and long-term effects of positive airway pressure (PAP) therapy on gas exchange, sleepiness, quality of life, depression and death rate in patients with obesity hypoventilation syndrome (OHS). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Obesity Hypoventilation Syndrome
- What is being tested?
- Positive airway pressure (PAP)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 252 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2009to 1 Jun 2012
- Phase
- Interventional
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged between 18 and 80 years
- Obesity hypoventilation syndrome diagnosis (OHS)
- clinically stable for at least 4 weeks prior to the enrolmenT
- above-elementary school education.
Who cannot join
- refusal to participate
- refusal of PAP therapy
- central sleep apnea syndromes
- restrictive ventilation syndromes
- severe congestive heart failure
- a history of life-threatening arrhythmias
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- severe cardiomyopathy
- significant chronic kidney disease
- untreated hypothyroidism
- family or personal history of mental illness
- drug or alcohol abuse
- sedative use
- severe cognitive impairment
- concurrent oncological diseases
- history of narcolepsy or restless legs syndrome.
About this study
Official title: PAP Therapy Compliance in Patients With Obesity Hypoventilation Syndrome
The role of different levels of compliance and long-term effects of positive airway pressure (PAP) therapy on gas exchange, sleepiness, quality of life, depression and death rate in patients with obesity hypoventilation syndrome (OHS).
Read the detailed description
Various forms of positive airway pressure (PAP) therapy are effective in providing short and long-term benefits in these patients with or without obstructive sleep apnea (OSA). However, there are limited data concerning the impact of long-term effects of PAP therapy on survival and functional status in individuals with obesity hypoventilation syndrome (OHS) and OSA. Therefore we aimed to assess the role of different levels of compliance and long-term effects of PAP on gas exchange, sleepiness, quality of life, depression and death rate in patients with OHS, two year after PAP initiation.
- Conditions
- Obesity Hypoventilation Syndrome
- Being tested
- Positive airway pressure (PAP)
- 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.
Positive airway pressure (PAP)Device
Positive airway pressure (PAP) is a mode of respiratory ventilation used in the treatment of sleep apnea.
| Study group | Role | What they receive |
|---|---|---|
| Positive airway pressure (PAP) treatment | Other | Positive airway pressure (PAP),which reverses upper airway obstruction, is effective in the majority of patients with stable obesity hypoventilation syndrome (OHS). Receives: Device: Positive airway pressure (PAP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effects of positive airway pressure (PAP) therapy on gas exchange
Effects of positive airway pressure (PAP) therapy on arterial blood gases measurements
Measured: 2 years
Secondary outcomes (4)
Effects of positive airway pressure (PAP) therapy on sleepiness
Effects of positive airway pressure (PAP) therapy on epwoth Sleepiness scale score
Measured: 2 years
Effects of positive airway pressure (PAP) therapy on quality of life
Effects of positive airway pressure (PAP) therapy on Short Form -36 questionnaire
Measured: 2 years
Effects of positive airway pressure (PAP) therapy on depression
Effects of positive airway pressure (PAP) therapy on Beck Depression Inventory questionnaire
Measured: 2 years
Effects of positive airway pressure (PAP) therapy on death rate
Effects of positive airway pressure (PAP) therapy on number of deaths
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2018
- Study start1 Jun 2009
- Primary completion1 Jun 2012
- Study completion1 Jun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 252 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Crete
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Izolde Bouloukaki, University of Crete
- Investigators
- Sophia Schiza, MD, PhD, Study chair, University of Crete
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03449641
- Sponsor's protocol ID
- OHSPAP1
- Status last verified
- Feb 2018
- First submitted
- 22 Feb 2018
- Last updated
- 1 Mar 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bouloukaki I, Mermigkis C, Michelakis S, Moniaki V, Mauroudi E, Tzanakis N, Schiza SE. The Association Between Adherence to Positive Airway Pressure Therapy and Long-Term Outcomes in Patients With Obesity Hypoventilation Syndrome: A Prospective Observational Study. J Clin Sleep Med. 2018 Sep 15;14(9):1539-1550. doi: 10.5664/jcsm.7332.
PubMed 30176976
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PAP Therapy Compliance in Patients With Obesity Hypoventilation Syndrome
- ClinicalTrials.gov ID
- NCT03449641
- Acronym / sponsor ID
- OHSPAP1
- Conditions
- Obesity Hypoventilation Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 252 participants (actual)
- Lead sponsor
- University of CreteUniversity, hospital or other
- Study start
- 1 Jun 2009 (actual)
- Primary completion
- 1 Jun 2012 (actual)
- Study completion
- 1 Jun 2012 (actual)
- First posted
- 28 Feb 2018 (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 role of different levels of compliance and long-term effects of positive airway pressure (PAP) therapy on gas exchange, sleepiness, quality of life, depression and death rate in patients with obesity hypoventilation syndrome (OHS).
Detailed description
Various forms of positive airway pressure (PAP) therapy are effective in providing short and long-term benefits in these patients with or without obstructive sleep apnea (OSA). However, there are limited data concerning the impact of long-term effects of PAP therapy on survival and functional status in individuals with obesity hypoventilation syndrome (OHS) and OSA. Therefore we aimed to assess the role of different levels of compliance and long-term effects of PAP on gas exchange, sleepiness, quality of life, depression and death rate in patients with OHS, two year after PAP initiation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Positive airway pressure (PAP) treatment | Other | Device: Positive airway pressure (PAP)Positive airway pressure (PAP),which reverses upper airway obstruction, is effective in the majority of patients with stable obesity hypoventilation syndrome (OHS). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- aged between 18 and 80 years
- Obesity hypoventilation syndrome diagnosis (OHS)
- clinically stable for at least 4 weeks prior to the enrolmenT
- above-elementary school education.
Key exclusion criteria (15 listed)
- refusal to participate
- refusal of PAP therapy
- central sleep apnea syndromes
- restrictive ventilation syndromes
- severe congestive heart failure
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 |
|---|---|---|
| Positive airway pressure (PAP)Positive airway pressure (PAP) is a mode of respiratory ventilation used in the treatment of sleep apnea. | Device | Positive airway pressure (PAP) treatment |
Primary outcome
Effects of positive airway pressure (PAP) therapy on gas exchange
Time frame: 2 years
Effects of positive airway pressure (PAP) therapy on arterial blood gases measurements
4 secondary outcomes
Effects of positive airway pressure (PAP) therapy on sleepiness
Time frame: 2 years
Effects of positive airway pressure (PAP) therapy on quality of life
Time frame: 2 years
Effects of positive airway pressure (PAP) therapy on depression
Time frame: 2 years
Effects of positive airway pressure (PAP) therapy on death rate
Time frame: 2 years
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 1 Mar 2018.
- Derived from this study: PubMed 30176976Bouloukaki I, Mermigkis C, Michelakis S, Moniaki V, Mauroudi E, Tzanakis N, Schiza SE. The Association Between Adherence to Positive Airway Pressure Therapy and Long-Term Outcomes in Patients With Obesity Hypoventilation Syndrome: A Prospective Observational Study. J Clin Sleep Med. 2018 Sep 15;14(9):1539-1550. doi: 10.5664/jcsm.7332.
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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.
Sophia Schiza, MD, PhD study chair
University of Crete
Questions about this trial
What is this clinical trial studying?
A study testing Positive airway pressure (PAP) in people with Obesity Hypoventilation Syndrome, run by University of Crete.
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 4 inclusion and 15 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 1 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Effects of positive airway pressure (PAP) therapy on gas exchange (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03449641, which also lists 1 linked publication.
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 1 Mar 2018.