Medico-economics and QoL of Obese Patients Followed by Medical Analysis Laboratories (BIOSAOS )

NCT03861468 | Withdrawn DMC

• 1 other identifier: 38RC17.360
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Obesity is a major risk factor for obstructive sleep apnea (OSA). However, OSA is still largely under diagnosed in patients with a high cardiovascular risk. In this population the STOP-BANG questionnaire facilitates OSA screening. Moreover, blood bicarbonate concentration is a simple tool to screen for chronic respiratory disease and if elevated, is a marker of cardiometabolic comorbidities in obese patients. A combination of blood bicarbonate concentration and STOP BANG score could provide a cost-effective method of screening for OSA in obese patients. Such screening could enable earlier management and might significantly reduce the costs of treatment and improve the quality of life of patients at 2 years.

Conditions

Obesity Hypoventilation Syndrome; Obstructive Sleep Apnea

Keywords

obesity hypoventilation syndrome; obstructive sleep apnea; bicarbonates; STOP-BANG

Outcome Measures

Primary Outcomes (1)

• 2-year medico-economic impact of the implementation of early care in obese patients with OSA

  incremental cost-effectiveness ratio at 24 months calculated from the difference in healthcare costs between the 2 groups (early care vs usual care) adjusted to the difference in the number of quality adjusted life years

  24 months

Secondary Outcomes (33)

• Economic impact of the implementation of early care in obese patients with OSA over 3 years on the healthcare costs

  3 years

• To evaluate the sensitivity of the screening tool

  24 months

• To evaluate the specificity of the screening tool

  24 months

• To evaluate the negative Predictive Value

  24 months

• To evaluate the positive predictive value of the screening tool

  24 months

Study Arms (2)

Usual care

NO INTERVENTION

Patients in the usual care group will be referred to their general practitioner (GP) / primary care practitioner as usual.

Early care

ACTIVE COMPARATOR

A different care pathway will be followed by the patients randomized to this group. They will be referred to a specialist (pneumologist) for OSA diagnosis and treatment if necessary

Other: Care pathway

Interventions

Care pathway OTHER

Screening for OSA using a combination of bicarbonate assay and STOP-BANG questionnaire and further management by a pneumologist as necessary

Early care

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged from 18 to 80 years
• Obese (BMI ≥ 30kg/m²)
• Referred by GPs to the medical analysis laboratory for usual biological assessment
• Patients with no respiratory follow-up already in place
• Patient affiliated with a social protection plan
• Bicarbonate - Concentration ≥ 27 mmol/L
• STOP-BANG score ≥ 3
• Informed written consent signed by the patient

You may not qualify if:

• Acute disease or recently diagnosed chronic disease (\< 2 months)
• Hospitalization for respiratory, metabolic or cardiovascular event (\< 2 months)
• Renal insufficiency stage 4 or 5, or autoimmune disease, or viral hepatitis, or cirrhosis
• Cited persons in Sections L1121-5 to L1121-8 of the CSP (pregnant woman, parturient, nursing mother, person deprived of liberty by judicial or administrative decision, a person who is the subject of a judicial or administrative legal protection)
• Patients already included in an interventional study (end of the study \< 1 month)

Sponsors & Collaborators

• University Hospital, Grenoble: lead
• University Hospital, Angers: collaborator
• Poitiers University Hospital: collaborator
• Union hospital, Toulouse: collaborator
• Hospital Alpes Leman, Annemasse: collaborator
• Hospital La Louvière, Lille: collaborator
• Oriade Laboratory, Vizille: collaborator
• Cerballiance laboratories, Lille: collaborator
• Oriade laboratory, Annemasse: collaborator

Study Sites (1)

ORIADE

Vizille, France

Location

MeSH Terms

Conditions

Obesity Hypoventilation Syndrome; Sleep Apnea, Obstructive

Interventions

Critical Pathways

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Hypoventilation; Respiratory Insufficiency; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Patient Care Planning; Comprehensive Health Care; Patient Care Management; Health Services Administration

Study Officials

• Jean-Louis PEPIN, MD, PhD

  Grenoble Alpes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Open, controlled, randomized clinical trial (cluster randomization)

Study Record Dates

• First Submitted: February 22, 2019
• First Posted: March 4, 2019
• Study Start: September 14, 2019
• Primary Completion: December 6, 2022
• Study Completion: December 6, 2022
• Last Updated: January 5, 2023

Record last verified: 2023-01

Locations

FR (1)