NCT00456651

Brief 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 energetic balance, causing an alteration in the secretion of hormones that favour the appearance and/or development of obesity.

Trial Health

55
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 4, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 5, 2007

Completed
Last Updated

April 5, 2007

Status Verified

April 1, 2007

First QC Date

April 4, 2007

Last Update Submit

April 4, 2007

Conditions

Sleep ApneaObesity

Keywords

Sleep ApneaObesityNeuropeptidesHormones

Outcome Measures

Primary Outcomes (4)

  • 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

Interventions

CPAP (Continuous Positive Airway Pressure)DEVICE

Eligibility Criteria

Age25 Years - 65 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Apnea-Hypopnea Index \> 15
  • Body Mass Index \< 27 or \> 30 Kg/m2

You may not qualify if:

  • Presence of any chronic disease
  • Drug addiction and/or alcoholism
  • Refusal to sign informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario Son Dureta

Palma de Mallorca, Balearic Islands, 07001, Spain

RECRUITING

MeSH Terms

Conditions

Sleep Apnea SyndromesObesity

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Positive-Pressure RespirationRespiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

Study Officials

  • Mónica de la Peña, MD

    Hospital Universitario Son Dureta

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mónica de la Peña, MD

CONTACT

34 971 175112mdelapena@hsd.es

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 4, 2007

First Posted

April 5, 2007

Study Start

February 1, 2007

Last Updated

April 5, 2007

Record last verified: 2007-04

Locations

ES(1)