A Study of Surgical Weight Loss to Treat Obstructive Sleep Apnea

Summary

Obesity is an increasing problem worldwide. Over 20% of people in western societies are obese (BMI \>30kg/m2) and 1-2 % are morbidly obese (BMI \>40 kg/m2). According to the recent study 6.6% of Finns are severely obese (BMI \> 35kg/m2) and 2.0% are morbidly obese (BMI\>40kg/m2). Because conventional treatments often fail to induce sustained weight loss obesity surgery has increased rapidly in many countries. Currently, \> 300000 procedures are performed in the US each year. Thus in many European countries, including Finland, the need for obesity surgery is rapidly increasing.

The most important risk factor also for obstructive sleep apnea (OSA) is obesity, and thus effective treatment of obesity is the first-line treatment of OSA. However, Reliable information of the prevalence of OSA in morbidly obese patients is still lacking. The current knowledge is based on small studies, which have demonstrated that the prevalence of OSA may be higher than believed, even 70-80% in morbidly obese patients. There is a definite need for large, well-designed, prospective clinical studies to evaluate the effects of weight reduction in OSA and other co-morbidities related to obesity. Ever increasing research data showing a strong link between obesity and OSA and their co-existence as a major risk factor in the development of cardiovascular diseases should provoke concepts to search better clinical guidelines of diagnostics and treatments in a risk group, such as morbidly obese patients.

Conditions

• Obstructive Sleep Apnea
• Obesity

Interventions

PROCEDURE

Bariatric surgery

A standardized laparoscopic gastric bypass using Roux-en-Y technique

DEVICE

Continuous positive airway pressure

The patients are given standardized CPAP treatment according to current clinical guidelines.

Sponsors & Collaborators

• Helsinki University Central Hospital

  collaborator OTHER

• Turku University Hospital

  collaborator OTHER_GOV

• Oulu University Hospital

  collaborator OTHER

• Vaasa Central Hospital, Vaasa, Finland

  collaborator OTHER

• Finnish Institute for Health and Welfare

  collaborator OTHER_GOV

• Helsingin Uniklinikka

  collaborator UNKNOWN

• Kanta-Häme Central Hospital

  collaborator OTHER_GOV

• Kuopio University Hospital

  lead OTHER

Principal Investigators

• Henri Tuomilehto, MD, PhD · Kuopio University Hospital

• Mikael Victorzon, MD, PhD · Vaasa Central Hospital, Vaasa, Finland

• Jussi Pihlajamäki, MD, PhD · Kuopio University Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-05-31

Primary Completion

2021-12-31

Completion

2021-12-31

Countries

• Finland

Study Locations