NCT02832414

Brief Summary

The purpose of this study is to determine if a lifestyle change program for obese patients who are already receiving continuous positive airway pressure (CPAP) treatment can achieve weight loss and overall improvement of obstructive sleep apnea syndrome (OSAS).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

July 6, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 14, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

August 13, 2019

Status Verified

August 1, 2019

Enrollment Period

1.9 years

First QC Date

July 6, 2016

Last Update Submit

August 9, 2019

Conditions

Sleep Apnea, ObstructiveObesity

Outcome Measures

Primary Outcomes (1)

  • Improvement in the apnea-hypopnea index/hour: Sleep study: Standard polysomnography

    Assess whether a lifestyle change program can be effective in the medium and long term for the treatment of OSAS in obese patients with OSAS who are already receiving CPAP treatment.

    Baseline, at 3 months and 12 months.

Secondary Outcomes (48)

  • waist circumference (above the upper iliac crest): centimetre

    Baseline, at 3 months and 12 months.

  • neck circumfarence: centimetre

    Baseline, at 3 months and 12 months.

  • waist to hip ratio

    Baseline, at 3 months and 12 months.

  • Measurement of visceral fat (square centimetre) by an abdominal computerized tomography (CT) scan

    Baseline, at 12 months.

  • Carotid intima-media (C-IMT) thickness (millimeter (mm)) by ultrasound of the supra-aortic vessels, using B-mode ultrasound

    Baseline, at 3 months and 12 months.

  • +43 more secondary outcomes

Study Arms (2)

Regular program

NO INTERVENTION

Intensive weight loss program

ACTIVE COMPARATOR
Behavioral: Intensive weight loss program

Interventions

Intensive weight loss programBEHAVIORAL

behavioral and dietary supplement

Intensive weight loss program

Eligibility Criteria

Age25 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients who have been diagnosed with severe obstructive sleep apnea syndrome (AHI \> 30) and are already receiving CPAP treatment (since at least 6 months), who have class I and class II obesity (body mass index (BMI) \>= 30 kg /m2 y \<= 40 kg/m2).

You may not qualify if:

  • diseases that limit exercising or diet,
  • cognitive impairment that prevents understanding the program,
  • psychiatric disorders,
  • severe diseases, major cardiovascular disease,
  • clinical instability within the previous month,
  • prior bariatric surgery,
  • refusal to participate in the study,
  • participation in another clinical trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona, Spain

Location

Related Publications (1)

  • Lopez-Padros C, Salord N, Alves C, Vilarrasa N, Gasa M, Planas R, Montsserrat M, Virgili MN, Rodriguez C, Perez-Ramos S, Lopez-Cadena E, Ramos MI, Dorca J, Monasterio C. Effectiveness of an intensive weight-loss program for severe OSA in patients undergoing CPAP treatment: a randomized controlled trial. J Clin Sleep Med. 2020 Apr 15;16(4):503-514. doi: 10.5664/jcsm.8252.

    PMID: 32003737DERIVED

MeSH Terms

Conditions

Sleep Apnea, ObstructiveObesity

Condition Hierarchy (Ancestors)

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

Study Officials

  • Carmen Monasterio Ponsa, Doctor

    Hospital Universitari Bellvitge

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

July 6, 2016

First Posted

July 14, 2016

Study Start

July 1, 2016

Primary Completion

June 1, 2018

Study Completion

June 1, 2018

Last Updated

August 13, 2019

Record last verified: 2019-08

Locations

ES(1)