search
Back to results

Obstructive Sleep Apnea, Predictors and Bariatric Surgery

Primary Purpose

Obesity, Obstructive Sleep Apnea, Bariatric Surgery Candidate

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Bariatric surgery
Sponsored by
Catholic University of the Sacred Heart
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Obesity, Obstructive sleep apnea, Bariatric surgery candidate, Metabolic syndrome

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • BMI above 30 kg/m2
  • Age between 20 and 70 years
  • Willingness to understand the protocol and willingness to participate in the study

Exclusion Criteria:

  • Exclusion criteria is severe co-morbidities that would prevent the patients to undergo bariatric surgery. Such as severe anemia, severe heart failure, active or previous malignancies the last 5 years. Myocardial infarction or unstable angina pectoris the last 6 months. Pregnancy. Suspected poor compliance. Drug or alcohol abuse. Major gastrointestinal disease.
  • Inability to undergo polysomnography.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    No Intervention

    Arm Label

    Biliopancreatic diversion

    Gastric sleeve

    Gastric bypass

    No intervention

    Arm Description

    Study participants will undergo biliopancreatic diversion which is a type of bariatric surgery where a part of the stomach are removed and the remaining stomach is attached to a distal segment of the small intestine.

    Study participants will undergo sleeve gastrectomy which is a restrictive form av bariatric surgery where the size of the stomach is reduced.

    Study participants will undergo gastric bypass which is a type of bariatric surgery where a small pouch of the stomach is created and attached to a segment of the small intestine.

    Study participants that do not want to undergo surgical treatment.

    Outcomes

    Primary Outcome Measures

    Change in severity of obstructive sleep apnea measured by a overnight cardio-respiratory monitoring before and 5 years after bariatric surgery.
    The effect of bariatric surgery as a treatment of obstructive sleep apnea in patients with obesity will be evaluated as the change in obstructive sleep apnea severity. To address this aim a overnight cardio-respiratory monitoring with a Vital Night 8 device (Vital Aire, Milan, Italy) will be performed before and 5 years after bariatric surgery.

    Secondary Outcome Measures

    Full Information

    First Posted
    July 14, 2017
    Last Updated
    July 13, 2020
    Sponsor
    Catholic University of the Sacred Heart
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT03223467
    Brief Title
    Obstructive Sleep Apnea, Predictors and Bariatric Surgery
    Official Title
    Effect of Bariatric Surgery on Obstructive Sleep Apnea and Predictors for the Severity of Obstructive Sleep Apnea
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    January 4, 2012 (Actual)
    Primary Completion Date
    December 30, 2017 (Actual)
    Study Completion Date
    December 30, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Catholic University of the Sacred Heart

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Obstructive sleep apnea is defined as a repetitive collapse of the pharynx during sleep (Malhotra, et al. 2012) which cases intermittent hypoxia. Snoring, witnessed apnea, fatigue and morning headache are symptoms of the disease which has severe health effect (Malhotra. et al. 2012) including increased mortality risk (Ensrud. et al. 2012) and effects on quality of life (Kuhn. et al. 2017). Obesity, male sex and age are all risk factors for obstructive sleep apnea (Schwartz. et al. 2010, Edwards. et al. 2010) . Bariatric surgery is known to be a good treatment to achieve a sustained weight loss but the long term effects of bariatric treatment of obstructive sleep apnea is not well studied. The aim of this study is therefore to study the long effects of bariatric surgery as a treatment for obstructive sleep apnea and to find predictors that can be used to predict the severity of the disease.
    Detailed Description
    Obstructive sleep apnea is defined as a repetitive collapse of the pharynx during sleep (Malhotra, et al. 2012) which cases intermittent hypoxia. Snoring, witnessed apnea, fatigue and morning headache are symptoms of the disease which has severe health effect (Malhotra. et al. 2012) including increased mortality (Ensrud. et al. 2012) and effects on quality of life (Kuhn. et al. 2017). Hence, identifying and treat obstructive sleep apnea are important. Obesity, male sex and age are all risk factors for obstructive sleep apnea (Schwartz et. al. 2010, Edwards. et. al. 2010) . Bariatric surgery is known to be a good treatment to achieve a sustained weight loss but the long term effects of bariatric treatment of obstructive sleep apnea is not well studied. The aim of this study is therefore to study the long effects of bariatric surgery as a treatment for obstructive sleep apnea and to find predictors that can be used to predict the severity of the disease. Eighty-six patients with obesity have been recruited at the Catholic University hospital in Rome, Italy during 2012 when patients were enrolled during their evaluation for bariatric surgery. At baseline, the patient underwent fasting blood chemistry, anthropometric measurements and overnight polysomnography. The patients also underwent a 3 hour oral glucose tolerance test in order to determinate glucose tolerance (normal glucose tolerance, impaired glucose tolerance and type 2 diabetes mellitus). Patient then received treatment with bariatric surgery (gastric sleeve, biliopancreatic diversion or gastric bypass) during 2012-2013 or decided not to undergo bariatric surgery. Patient will undergo follow-up during 2016-2017 where fasting blood chemistry, anthropometric measurements and overnight polysomnography will be assessed. The patient will also undergo a 3 hour oral glucose tolerance test. The effects of bariatric surgery on obstructive sleep apnea will then be evaluated. Differences in the treatment effect between the different bariatric surgical procedures will be studied. Patients characteristics at baseline, such as weight, height, BMI and components of the metabolic syndrome and their association to the severity of obstructive sleep apnea will be studied in order to find predictors for the severity of the disease.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Obesity, Obstructive Sleep Apnea, Bariatric Surgery Candidate
    Keywords
    Obesity, Obstructive sleep apnea, Bariatric surgery candidate, Metabolic syndrome

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Patients in this study underwent either gastric bypass, gastric sleeve or biliopancreatic diversion. Some patient choose not to undergo bariatric surgery and function as a control arm.
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    86 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Biliopancreatic diversion
    Arm Type
    Active Comparator
    Arm Description
    Study participants will undergo biliopancreatic diversion which is a type of bariatric surgery where a part of the stomach are removed and the remaining stomach is attached to a distal segment of the small intestine.
    Arm Title
    Gastric sleeve
    Arm Type
    Active Comparator
    Arm Description
    Study participants will undergo sleeve gastrectomy which is a restrictive form av bariatric surgery where the size of the stomach is reduced.
    Arm Title
    Gastric bypass
    Arm Type
    Active Comparator
    Arm Description
    Study participants will undergo gastric bypass which is a type of bariatric surgery where a small pouch of the stomach is created and attached to a segment of the small intestine.
    Arm Title
    No intervention
    Arm Type
    No Intervention
    Arm Description
    Study participants that do not want to undergo surgical treatment.
    Intervention Type
    Procedure
    Intervention Name(s)
    Bariatric surgery
    Intervention Description
    Bariatric surgery includes several different types of surgical procedures used to achieve weight loss.
    Primary Outcome Measure Information:
    Title
    Change in severity of obstructive sleep apnea measured by a overnight cardio-respiratory monitoring before and 5 years after bariatric surgery.
    Description
    The effect of bariatric surgery as a treatment of obstructive sleep apnea in patients with obesity will be evaluated as the change in obstructive sleep apnea severity. To address this aim a overnight cardio-respiratory monitoring with a Vital Night 8 device (Vital Aire, Milan, Italy) will be performed before and 5 years after bariatric surgery.
    Time Frame
    5 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: BMI above 30 kg/m2 Age between 20 and 70 years Willingness to understand the protocol and willingness to participate in the study Exclusion Criteria: Exclusion criteria is severe co-morbidities that would prevent the patients to undergo bariatric surgery. Such as severe anemia, severe heart failure, active or previous malignancies the last 5 years. Myocardial infarction or unstable angina pectoris the last 6 months. Pregnancy. Suspected poor compliance. Drug or alcohol abuse. Major gastrointestinal disease. Inability to undergo polysomnography.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Geltrude Mingrone, MD. PhD.
    Organizational Affiliation
    The Catholic University of the Sacred Heart
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    12133673
    Citation
    Malhotra A, White DP. Obstructive sleep apnoea. Lancet. 2002 Jul 20;360(9328):237-45. doi: 10.1016/S0140-6736(02)09464-3.
    Results Reference
    background
    PubMed Identifier
    22705247
    Citation
    Ensrud KE, Blackwell TL, Ancoli-Israel S, Redline S, Cawthon PM, Paudel ML, Dam TT, Stone KL. Sleep disturbances and risk of frailty and mortality in older men. Sleep Med. 2012 Dec;13(10):1217-25. doi: 10.1016/j.sleep.2012.04.010. Epub 2012 Jun 15.
    Results Reference
    background
    PubMed Identifier
    28130044
    Citation
    Kuhn E, Schwarz EI, Bratton DJ, Rossi VA, Kohler M. Effects of CPAP and Mandibular Advancement Devices on Health-Related Quality of Life in OSA: A Systematic Review and Meta-analysis. Chest. 2017 Apr;151(4):786-794. doi: 10.1016/j.chest.2017.01.020. Epub 2017 Jan 24.
    Results Reference
    background
    PubMed Identifier
    19875707
    Citation
    Schwartz AR, Patil SP, Squier S, Schneider H, Kirkness JP, Smith PL. Obesity and upper airway control during sleep. J Appl Physiol (1985). 2010 Feb;108(2):430-5. doi: 10.1152/japplphysiol.00919.2009. Epub 2009 Oct 29.
    Results Reference
    background
    PubMed Identifier
    20941662
    Citation
    Edwards BA, O'Driscoll DM, Ali A, Jordan AS, Trinder J, Malhotra A. Aging and sleep: physiology and pathophysiology. Semin Respir Crit Care Med. 2010 Oct;31(5):618-33. doi: 10.1055/s-0030-1265902. Epub 2010 Oct 12.
    Results Reference
    background

    Learn more about this trial

    Obstructive Sleep Apnea, Predictors and Bariatric Surgery

    We'll reach out to this number within 24 hrs