Obstructive Sleep Apnea, Predictors and Bariatric Surgery

NCT03223467 | Completed

• 1 other identifier: OSA2012
• Study Type: interventional
• Target: 86
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Obesity; Obstructive Sleep Apnea; Bariatric Surgery Candidate

Keywords

Obesity; Obstructive sleep apnea; Bariatric surgery candidate; Metabolic syndrome

Outcome Measures

Primary Outcomes (1)

• 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.

  5 years

Study Arms (4)

Biliopancreatic diversion

ACTIVE COMPARATOR

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.

Procedure: Bariatric surgery

Gastric sleeve

ACTIVE COMPARATOR

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

Procedure: Bariatric surgery

Gastric bypass

ACTIVE COMPARATOR

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.

Procedure: Bariatric surgery

No intervention

NO INTERVENTION

Study participants that do not want to undergo surgical treatment.

Interventions

Bariatric surgery PROCEDURE

Bariatric surgery includes several different types of surgical procedures used to achieve weight loss.

Biliopancreatic diversion; Gastric bypass; Gastric sleeve

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Inability to undergo polysomnography.

Sponsors & Collaborators

• Catholic University of the Sacred Heart: lead

Related Publications (5)

• Malhotra A, White DP. Obstructive sleep apnoea. Lancet. 2002 Jul 20;360(9328):237-45. doi: 10.1016/S0140-6736(02)09464-3.

  PMID: 12133673 BACKGROUND

• 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.

  PMID: 22705247 BACKGROUND

• 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.

  PMID: 28130044 BACKGROUND

• 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.

  PMID: 19875707 BACKGROUND

• 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.

  PMID: 20941662 BACKGROUND

MeSH Terms

Conditions

Obesity; Sleep Apnea, Obstructive; Metabolic Syndrome

Interventions

Bariatric Surgery

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases

Intervention Hierarchy (Ancestors)

Bariatrics; Obesity Management; Therapeutics; Surgical Procedures, Operative

Study Officials

• Geltrude Mingrone, MD. PhD.

  The Catholic University of the Sacred Heart

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: 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.

Study Record Dates

• First Submitted: July 14, 2017
• First Posted: July 21, 2017
• Study Start: January 4, 2012
• Primary Completion: December 30, 2017
• Study Completion: December 30, 2017
• Last Updated: July 14, 2020

Record last verified: 2020-07