Sleep ApneaNCT00456651
Sleep Apnea-Hypopnea Syndrome and the Pathogenesis of Obesity
A study testing CPAP (Continuous Positive Airway Pressure) in people with Sleep Apnea and Obesity, run by Sociedad Española de Neumología y Cirugía Torácica at 1 site in Spain.
Trial summary
The hypothesis of the study is the following: Patients with sleep apnea-hypopnea syndrome have different pattern in the secretion of hormones. The chronic sleep disorganization that suffer patients with sleep apnea-hypopnea syndrome (SAHS) may affect the central mechanisms that regulate nutritive behavior and… Read more about this study
- Who is it for?
- Ages 25 to 65 years, men only
- Conditions the study is for
- Sleep Apnea, Obesity
- What is being tested?
- CPAP (Continuous Positive Airway Pressure)
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- Feb 2007to not given
- 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 25 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Apnea-Hypopnea Index > 15
- Body Mass Index < 27 or > 30 Kg/m2
Who cannot join
- Presence of any chronic disease
- Drug addiction and/or alcoholism
- Refusal to sign informed consent
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario Son Dureta
Palma de Mallorca, Balearic Islands, 07001
About this study
The hypothesis of the study is the following: Patients with sleep apnea-hypopnea syndrome have different pattern in the secretion of hormones.
The chronic sleep disorganization that suffer patients with sleep apnea-hypopnea syndrome (SAHS) may affect the central mechanisms that regulate nutritive behavior and energetic balance, causing an alteration in the secretion of hormones that favour the appearance and/or development of obesity.
Read the detailed description
OBJECTIVES: To compare the plasmatic profiles of different hormones and neuropeptides, related with weight control, metabolism and intake in patients with SAHS as well as in selected control subjects according to weight.
DESIGN: Multicenter, prospective and controlled study. 40 patients with SAHS will be included as well as 40 control subjects.
METHODS: To all subjects included in the study, the following procedures will be performed:
- Medical History;
- Anthropometric variables (height, weight, Body Mass Index;
- Somnolence evaluation using the Epworth scale;
- Conventional Polysomnography (PSG);
- Determination every four hours during a 24 hours period of the levels of leptin adiponectin, resistin, insulin, PCR, etc.
- Conventional biologic evaluation;
- Patients will be re-evaluated after three months of treatment with CPAP.
- Conditions
- Sleep Apnea, Obesity
- Being tested
- CPAP (Continuous Positive Airway Pressure)
- Keywords
- Sleep Apnea, Obesity, Neuropeptides, Hormones
- Medical subject headings
- Sleep Apnea Syndromes, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPAP (Continuous Positive Airway Pressure)Device
What is being measured
The primary outcome is the main question the study is designed to answer.
OBJECTIVES: To compare the plasmatic profiles of different hormones
and neuropeptides, related with weight control, metabolism and intake
in patients with SAHS as well as in selected control subjects according
to weight.
Secondary outcomes (1)
CPAP (Continuous Positive Airway Pressure) effect on studied variables
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2007 (estimated)
- Study startFeb 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep ApneaStudies 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- Sociedad Española de Neumología y Cirugía Torácica
- Sponsor type
- University, hospital or other
- Collaborators
- Fundacion Caubet-Cimera Islas Baleares, Fondo de Investigacion Sanitaria
- Investigators
- Mónica de la Peña, MD, Principal investigator, Hospital Universitario Son Dureta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00456651
- Sponsor's protocol ID
- IB570/05
- Status last verified
- Apr 2007
- First submitted
- 4 Apr 2007
- Last updated
- 5 Apr 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Apnea-Hypopnea Syndrome and the Pathogenesis of Obesity
- ClinicalTrials.gov ID
- NCT00456651
- Acronym / sponsor ID
- IB570/05
- Conditions
- Sleep Apnea, Obesity
- Keywords
- Sleep Apnea, Obesity, Neuropeptides, Hormones
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants
- Lead sponsor
- Sociedad Española de Neumología y Cirugía TorácicaUniversity, hospital or other
- Collaborators
- Fundacion Caubet-Cimera Islas Baleares, Fondo de Investigacion Sanitaria
- Study start
- Feb 2007
- First posted
- 5 Apr 2007 (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.
The hypothesis of the study is the following: Patients with sleep apnea-hypopnea syndrome have different pattern in the secretion of hormones.
The chronic sleep disorganization that suffer patients with sleep apnea-hypopnea syndrome (SAHS) may affect the central mechanisms that regulate nutritive behavior and energetic balance, causing an alteration in the secretion of hormones that favour the appearance and/or development of obesity.
Detailed description
OBJECTIVES: To compare the plasmatic profiles of different hormones and neuropeptides, related with weight control, metabolism and intake in patients with SAHS as well as in selected control subjects according to weight.
DESIGN: Multicenter, prospective and controlled study. 40 patients with SAHS will be included as well as 40 control subjects.
METHODS: To all subjects included in the study, the following procedures will be performed:
- Medical History;
- Anthropometric variables (height, weight, Body Mass Index;
- Somnolence evaluation using the Epworth scale;
- Conventional Polysomnography (PSG);
- Determination every four hours during a 24 hours period of the levels of leptin adiponectin, resistin, insulin, PCR, etc.
- Conventional biologic evaluation;
- Patients will be re-evaluated after three months of treatment with CPAP.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 25 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Apnea-Hypopnea Index > 15
- Body Mass Index < 27 or > 30 Kg/m2
Key exclusion criteria (3 listed)
- Presence of any chronic disease
- Drug addiction and/or alcoholism
- Refusal to sign informed consent
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 |
|---|---|---|
| CPAP (Continuous Positive Airway Pressure) | Device | – |
Primary outcome
OBJECTIVES: To compare the plasmatic profiles of different hormones
and neuropeptides, related with weight control, metabolism and intake
in patients with SAHS as well as in selected control subjects according
to weight.
1 secondary outcome
CPAP (Continuous Positive Airway Pressure) effect on studied variables
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2007.
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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.
Mónica de la Peña, MD principal investigator
Hospital Universitario Son Dureta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CPAP (Continuous Positive Airway Pressure) in people with Sleep Apnea and Obesity, run by Sociedad Española de Neumología y Cirugía Torácica at 1 site in Spain.
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 2 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: status not confirmed, as of the sponsor's last update on 5 Apr 2007. 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 Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mónica de la Peña, MD (34 971 175112, mdelapena@hsd.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
OBJECTIVES: To compare the plasmatic profiles of different hormones. The study lists 4 primary outcomes in all. 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 5 Apr 2007.