## Protocol Section
### Identification Module
**NCT ID:** NCT06432933

**Acronym:** OXYBAR

**Brief Title:** Comparison of Apnea-Hypopnea Index in Patients With or Without Preventive Oxygen Therapy After Bariatric Surgery

**Official Title:** Comparison of Apnea-Hypopnea Index, in Patients With Potentially Undiagnosed Obstructive Sleep Apnea, Treated With or Without Preventive Oxygen Therapy, During the First Night After Bariatric Surgery

#### Organization Study ID Info
**ID:** 2023-2352
#### Organization
**Class:** OTHER
**Full Name:** Rijnstate Hospital
### Status Module
#### Completion Date
**Date:** 2025-07

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-22

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2025-03

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-04-09

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-03
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Rijnstate Hospital

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The best perioperative strategy for obstructive sleep apnea (OSA) in bariatric surgery remains unclear. A strategy is to monitor patients and administer preventive oxygen therapy during the first postoperative night. However it is unknown what if preventive oxygen therapy is necessary.

The goal of this trial is to compare the Apnea-Hypopnea Index (AHI) in participants with or without preventive oxygen therapy.

Methods:

Participants are patients who underwent bariatric surgery without treated OSA and will be will be randomized into arm A or arm B:

Arm A: First postoperative night in the hospital with preventive oxygen therapy (standard care), Arm B: First postoperative night in hospital without preventive oxygen therapy (intervention).

**Detailed Description:** Rationale: The prevalence of obstructive sleep apnea (OSA) in the bariatric surgery population is high and mostly undiagnosed. The best perioperative strategy to manage sleep apnea in bariatric patients remains unclear. A recent study found that monitoring patients with pulsoximetry and giving them preventive oxygen therapy during the first postoperative night is safe and cost effective. In a population with patients with OSA but without obesity, no significant difference in apnea hypopnea index (AHI) was found between patients with and without oxygen therapy during the first postoperative night. The question was raised if preventive oxygen therapy during the first postoperative night after bariatric surgery is needed.

Objective: The primary objective of this study is to compare AHI in patients with potentially undiagnosed OSA, treated with or without preventive oxygen therapy, during the first night after bariatric surgery. The secondary objective of this study is to compare sleep architecture in these patients

Study design: This is a randomized controlled non-inferiority trial consisting of two arms; Arm A: First postoperative night in the hospital with preventive oxygen therapy (standard care), Arm B: First postoperative night in hospital without preventive oxygen therapy (intervention).

Study population: Patients scheduled for primary bariatric surgery without treated OSA Intervention: During the first postoperative night at the hospital patients in intervention arm B will not receive preventive oxygen therapy.

Main study parameters/endpoints: Primary endpoint is AHI and secondary endpoints are 30 days complications rate, nursing intervention rate and parameters for sleep architecture and sleep related breathing, score of the Epworth Sleepiness Scale (ESS) and STOP BANG.

### Conditions Module

**Conditions:**

- Obstructive Sleep Apnea

- Obesity

- Bariatric Surgery Candidate

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 152

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Other: No preventive oxygen therapy (2L)

**Label:** Without preventive oxygen therapy

**Type:** EXPERIMENTAL

#### Arm Group 2

**Intervention Names:**

- Other: Preventive oxygen therapy (2L) standard care

**Label:** With preventive oxygentherapy

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Without preventive oxygen therapy

**Description:** Participants will not receive preventive oxygen 2L during the first postoperative night after bariatric surgery.

**Name:** No preventive oxygen therapy (2L)

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- With preventive oxygentherapy

**Description:** Participants will receive preventive oxygen 2L during the first postoperative night after bariatric surgery, standard care.

**Name:** Preventive oxygen therapy (2L) standard care

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** AHI will be measured by a home sleep study device (Watchpat300) and will be compared between both arms, the higher the AHI the more severe the sleep apnea

**Measure:** Apnea-Hypopnea Index (AHI)

**Time Frame:** First postoperative night

#### Secondary Outcomes

**Description:** All complication will be scored and will be compared between both arms

**Measure:** Complication rate

**Time Frame:** Until 30 days after surgery

**Description:** Nursing interventions will be scored on a form and the number of nursing interventions will be compared between both arms

**Measure:** The number of nursing interventions

**Time Frame:** First postoperative night

**Description:** e.g. waking up the patient or starting or increasing oxygen therapy/flow, this will be compared between both arms.

**Measure:** Type of nursing interventions

**Time Frame:** First postoperative night

**Description:** ODI will be measured by a home sleep study device (Watchpat300) and will be compared between both arms

**Measure:** Oxygen Desaturation Index (ODI)

**Time Frame:** First postoperative night

**Description:** AHI during REM sleep will be measured by a home sleep study device (Watchpat300) and will be compared between both arms

**Measure:** AHI during Rapid Eye Movement (REM) sleep

**Time Frame:** First postoperative night

**Description:** RDI will be measured by a home sleep study device (Watchpat300) and will be compared between both arms

**Measure:** Respiratory disturbance index (RDI)

**Time Frame:** First postoperative night

**Description:** Mean saturation will be measured by a home sleep study device (Watchpat300) and will be compared between both arms

**Measure:** Mean saturation

**Time Frame:** First postoperative night

**Description:** Mean saturation during desaturations will be measured by a home sleep study device (Watchpat300) and will be compared between both arms

**Measure:** Mean saturation during desaturations,

**Time Frame:** First postoperative night

**Description:** Number of desaturations will be measured by a home sleep study device (Watchpat300) and will be compared between both arms

**Measure:** Number of desaturations

**Time Frame:** First postoperative night

**Description:** will be measured by a home sleep study device (Watchpat300) and will be compared between both arms

**Measure:** Percentage of saturation <90%

**Time Frame:** First postoperative night

**Description:** will be measured by a home sleep study device (Watchpat300) and will be compared between both arms

**Measure:** Percentage of saturation <88%

**Time Frame:** First postoperative night

**Description:** will be measured by a home sleep study device (Watchpat300) and will be compared between both arms

**Measure:** Percentage of saturation <85%

**Time Frame:** First postoperative night

**Description:** will be measured by a home sleep study device (Watchpat300) and will be compared between both arms

**Measure:** Percentage of saturation <80%

**Time Frame:** First postoperative night

**Description:** will be measured by a home sleep study device (Watchpat300) and will be compared between both arms

**Measure:** Percentage of saturation <70%

**Time Frame:** First postoperative night

**Description:** will be measured by a home sleep study device (Watchpat300) and will be compared between both arms

**Measure:** Time (minutes) of saturation <90%

**Time Frame:** First postoperative night

**Description:** will be measured by a home sleep study device (Watchpat300) and will be compared between both arms

**Measure:** Time (minutes) of saturation <88%

**Time Frame:** First postoperative night

**Description:** will be measured by a home sleep study device (Watchpat300) and will be compared between both arms

**Measure:** Time (minutes) of saturation <85%

**Time Frame:** First postoperative night

**Description:** will be measured by a home sleep study device (Watchpat300) and will be compared between both arms

**Measure:** Time (minutes) of saturation <80%

**Time Frame:** First postoperative night

**Description:** will be measured by a home sleep study device (Watchpat300) and will be compared between both arms

**Measure:** Time (minutes) of saturation <70%

**Time Frame:** First postoperative night

**Description:** Total sleep time will be measured by a home sleep study device (Watchpat300) and will be compared between both arms

**Measure:** Total sleep time (minutes)

**Time Frame:** First postoperative night

**Description:** Percentage of REM sleep will be measured by a home sleep study device (Watchpat300) and will be compared between both arms

**Measure:** Percentage of REM sleep in total sleep time

**Time Frame:** First postoperative night

**Description:** Percentage of Deep sleep will be measured by a home sleep study device (Watchpat300) and will be compared between both arms

**Measure:** Percentage of Deep sleep in total sleep time

**Time Frame:** First postoperative night

**Description:** Percentage of light sleep will be measured by a home sleep study device (Watchpat300) and will be compared between both arms

**Measure:** Percentage of light sleep in total sleep time

**Time Frame:** First postoperative night

**Description:** Percentage of awake time will be measured by a home sleep study device (Watchpat300) and will be compared between both arms

**Measure:** Percentage of awake time

**Time Frame:** First postoperative night

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Undergo primary bariatric surgery (RYGB or SG)
* Speak and read the Dutch language

Exclusion Criteria:

* Revisional bariatric surgery (e.g. sleeve conversion, RYGB after gastric banding)
* Same-day discharge after bariatric surgery
* Diagnosed OSA with treatment (CPAP, oral appliances)
* Professional drivers
* Use of alpha blockers
* Unable to speak or read the Dutch language

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** clberends@rijnstate.nl

**Name:** Claudia Berends, Msc

**Phone:** +31880055970

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Elst

**Contacts:**

***Contact 1:***

- **Email:** clberends@rijnstate.nl

- **Name:** Claudia Berends

- **Phone:** +31880055970

- **Role:** CONTACT

**Country:** Netherlands

**Facility:** Vitalys

**Status:** RECRUITING

**Zip:** 6662 NC

#### Overall Officials

**Official 1:**

**Affiliation:** Rijnstate Hospital

**Name:** Eric Hazebroek, Prof.dr.

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000012120

- Term: Respiration Disorders

- ID: D000012140

- Term: Respiratory Tract Diseases

- ID: D000012818

- Term: Signs and Symptoms, Respiratory

- ID: D000020919

- Term: Sleep Disorders, Intrinsic

- ID: D000020920

- Term: Dyssomnias

- ID: D000012893

- Term: Sleep Wake Disorders

- ID: D000009422

- Term: Nervous System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

### Condition Browse Module - Browse Leaves

- ID: M12701

- Name: Obesity

- Relevance: LOW

- As Found: Unknown

- ID: M4361

- Name: Apnea

- Relevance: HIGH

- As Found: Apnea

- ID: M15694

- Name: Sleep Apnea Syndromes

- Relevance: HIGH

- As Found: Sleep Apnea

- ID: M22010

- Name: Sleep Apnea, Obstructive

- Relevance: HIGH

- As Found: Obstructive Sleep Apnea

- ID: M16355

- Name: Syndrome

- Relevance: LOW

- As Found: Unknown

- ID: M14957

- Name: Respiration Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14977

- Name: Respiratory Tract Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M15623

- Name: Signs and Symptoms, Respiratory

- Relevance: LOW

- As Found: Unknown

- ID: M22242

- Name: Parasomnias

- Relevance: LOW

- As Found: Unknown

- ID: M22654

- Name: Sleep Disorders, Intrinsic

- Relevance: LOW

- As Found: Unknown

- ID: M22655

- Name: Dyssomnias

- Relevance: LOW

- As Found: Unknown

- ID: M15696

- Name: Sleep Wake Disorders

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000001049

- Term: Apnea

- ID: D000012891

- Term: Sleep Apnea Syndromes

- ID: D000020181

- Term: Sleep Apnea, Obstructive

### Misc Info Module

- Version Holder: 2024-05-31
