Assessment of pre- and postoperative Apnea-Hypopnea Index after Same-Day Discharge bariatric surgery in patients with potentially undiagnosed Obstructive Sleep Apnea

Assessment of pre- and postoperative Apnea-Hypopnea Index after Same-Day Discharge bariatric surgery in patients with potentially undiagnosed Obstructive Sleep Apnea - DAGBAR study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON56650

Enrollment

Registered

2024-03-20

Start date

2024-05-13

Completion date

Unknown

Last updated

2025-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

slaap gerelateerde stoornissen in respiratie Obstructive sleep apnea sleep disordered breathing

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Rijnstate criteria for SDD bariatric surgery: - Age >=18 years - During the first postoperative night an adult person (=caregiver)  must be  present at the home or residence of the patient, to seek medical attention  if needed - Both patient and caregiver must speak and read the Dutch language - During the first postoperative night the patients must reside within  a 60- minute radius of Rijnstate hospital (Arnhem) - Undergo primary bariatric surgery (RYGB or SG) - In possession and able to use a smartphone

Exclusion criteria

Exclusion criteria: - Rijnstate exclusion criteria for SDD bariatric surgery - Not living in the Netherlands - Patients from psychiatric wards, inmates of prisons and other state  institutions - Insulin dependent diabetes - Patients with active implants such as ICD and pacemaker - Patients using a beta-blocker - Patients diagnosed with OSA but without treatment - Revisional bariatric surgery (e.g. sleeve conversion, RYGB after gastric  banding) - Diagnosed OSA with treatment (CPAP, oral appliances) - Professional drivers - Use of alpha blockers - Unable to speak or read the Dutch language - Not in possession or not able to use a smartphone

Design outcomes

Primary

Measure	Time frame
Primary endpoint is Apnea-Hypopnea Index.	—

Secondary

Measure	Time frame
Secondary and tertiary endpoints are 30 days complications rate, and parameters for sleep architecture and sleep related breathing (in minutes and percentages; oxygenation desaturation index (ODI), Rapid eye movement (REM) sleep, deep sleep, light sleep, wake time, REM AHI , Respiratory disturbance index (RDI), Total sleep time, saturation <90%, mean saturation, mean saturation during desaturations, number of desaturations).	—

Measure

Time frame

Secondary and tertiary endpoints are 30 days complications rate, and parameters for sleep architecture and sleep related breathing (in minutes and percentages; oxygenation desaturation index (ODI), Rapid eye movement (REM) sleep, deep sleep, light sleep, wake time, REM AHI , Respiratory disturbance index (RDI), Total sleep time, saturation <90%, mean saturation, mean saturation during desaturations, number of desaturations).

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Countries

Netherlands

Outcome results