Pre- and Postoperative Apnea-Hypopnea Index After Same-Day Discharge Bariatric Surgery

NCT06452784 | Completed

• 1 other identifier: 2024-2418
• Study Type: observational
• Target: 103
• Locations: 1 country
• Sites: 1

Brief Summary

A recent development is same-day discharge in bariatric surgery, this seems to be safe if proper discharge criteria are used. However, yet there is no guideline for these discharge criteria, including for patients with (potential) Obstructive Sleep Apnea (OSA). To establish proper discharge criteria concerning OSA more information about (changes in) OSA during the first days after bariatric surgery is required. The aim of this study is to assess postoperative Apnea-Hypopnea Index (AHI) changes during the first and third night after Same-Day Discharge bariatric surgery in patients with potentially untreated OSA. Methods: Patients (n=60) will undergo a Home Sleep Apnea test , pre-operatively and during the first en third postoperative night after bariatric surgery to asses the AHI and sleep architecture.

Conditions

Obstructive Sleep Apnea; Bariatric Surgery Candidate; Same-day Discharge

Outcome Measures

Primary Outcomes (1)

• Apnea hypopnea index (AHI)

  The AHI will be measured by the Watchpat One and compared between the different timepoints.

  Measurements will take place 7 days before and 1 and 3 days after surgery

Secondary Outcomes (17)

• Oxygen Desaturation Index (ODI)

  Measurements will take place 7 days before and 1 and 3 days after surgery

• The AHI during rapid eye movement (sleep)

  Measurements will take place 7 days before and 1 and 3 days after surgery

• Respiratory disturbance index (RDI),

  Measurements will take place 7 days before and 1 and 3 days after surgery

• Percentage of time with a saturation <90%

  Measurements will take place 7 days before and 1 and 3 days after surgery

• Time of a saturation <90%

  Measurements will take place 7 days before and 1 and 3 days after surgery

Study Arms (1)

All study participants

Alle study participants will receive standard of care. For this study participants will complete two short questionnaires (the STOPBANG and ESS) and will undergo three home sleep apnea tests with the WatchPat one. These will be performed during the night seven days prior to surgery and during night one and three after surgery.

Eligibility Criteria

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

Study Population

Patients undergoing primary same-day discharge bariatric surgery, with exclusion of patients with treated OSA, patients using alpha blockers or professional drivers

You may qualify if:

• Undergo primary bariatric surgery (Roux and y gastric bypass or sleeve gastrectomy)
• Eligible for same-day discharge
• In possession and able to use a smartphone

You may not qualify if:

• Revisional bariatric surgery (e.g. sleeve conversion, RYGB after gastric banding)
• Not eligible for same-day discharge
• 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

Sponsors & Collaborators

• Rijnstate Hospital: lead

Study Sites (1)

Vitalys

Elst, 6662 NC, Netherlands

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Eric Hazebroek, Professor

  Vitalys part of Rijnstate

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2024
• First Posted: June 11, 2024
• Study Start: May 31, 2024
• Primary Completion: July 5, 2025
• Study Completion: July 5, 2025
• Last Updated: July 22, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)