Effect of High Flow Nasal Cannula Versus Continues Positive Airway Pressure in Adults With Obstructive Sleep Apnea

Not Applicable

• Conditions: Sleep Apnea
• Interventions: Device: Continuous Positive Airway Pressure (CPAP); Device: High Flow Nasal Cannula (HFNC)

• Registration Number: NCT05475119
• Lead Sponsor: King Abdulaziz University

Brief Summary

The participants whom undergo Polysomnography study (Sleep study) and are found to have mild, moderate or severe Obstructive Sleep Apnea (OSA) will have two consecutive titration nights. Randomly, they'll do (CPAP) titration followed by (HFNC) titration or vice versa. To explore the possibility of the CPAP not being superior to HFNC in reduction of sleep apnea events.

Detailed Description

The participants undergo three nights in the Sleep Lab. In their first night they perpetrate Polysomnography study (Sleep study) and then classifies to have mild, moderate or severe Obstructive Sleep Apnea (OSA) or not. Those who are diagnosed with OSA, will undergo two consecutive titration nights. Randomly, they'll do (CPAP) titration followed by (HFNC) titration or vice versa. To explore the possibility of the CPAP not being superior to HFNC in reduction of sleep apnea events.

Study Timeline

• Study Start: 2022-06-01
• Study First Submitted: 2022-06-22
• Status Verified: 2022-07
• Study First Submitted QC: 2022-07-24
• Last Update Submitted: 2022-07-24
• Study First Posted: 2022-07-26
• Last Update Posted: 2022-07-26
• Primary Completion: 2022-12-01
• Study Completion: 2022-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Adults patient aging above 18 years
• Diagnosed with Obstructive Sleep Apnea (OSA) based on Polysomnography (PSG) ranging from mild to severe i.e. more than 5

Exclusion Criteria

• Patients with hypoventilation syndrome
• Patients with chronic obstructive pulmonary disease
• Patients who have unstable hemodynamic state, who experienced intolerance to HFNC or CPAP
• Patients who are pregnant
• Patients recently underwent surgery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Participants diagnosed with Obstructive Sleep Apnea	Continuous Positive Airway Pressure (CPAP)	The participants will sleep three nights at the sleep lab and undergo in their first night, Polysomnography (PSG). Then at random, some of them will do CPAP titration in the second night followed by HFNC titration in the third night. While others will do HFNC titration in the second night followed by CPAP titration in the third night
Participants diagnosed with Obstructive Sleep Apnea	High Flow Nasal Cannula (HFNC)	The participants will sleep three nights at the sleep lab and undergo in their first night, Polysomnography (PSG). Then at random, some of them will do CPAP titration in the second night followed by HFNC titration in the third night. While others will do HFNC titration in the second night followed by CPAP titration in the third night

Primary Outcome Measures

Name	Time	Method
Sleep architecture while using High Flow Nasal Cannula oxygen device	two nights	Standard sleep architecture: sleep breathing disorder e.g. apnea, hypopnea, snoring Oxygenation : minimum oxygen saturation, duration of desaturation and number of desaturation Arousals : number and index
Apnea/Hypopnea Index count using High Flow Nasal Cannula oxygen device and Continuous Positive Pressure Airway device on patients with Obstructive Sleep Apnea	two nights	the Apnea/Hypopnea Index (AHI) is 5 events or less
Tolerance and acceptability of High Flow Nasal Cannula by patients compared to the standard Continuous Positive Airway Pressure	two nights	Comparison of High Flow Nasal Cannula device compared to the Continuous Positive Airway Pressure for a long term usage; being assessed in; 1. How well did you accept the device yesterday?; 2. How comfortable was the usage of the device?; 3. Was the used mask comfortable? (1)not acceptable, (2)tolerable, (3)acceptable, (4)well received, (5)excellent; 4. Did you face any difficulties breathing through your nose while using the device last night?; 5. Did you have any of these symptoms while using the mask last night? Nasal dryness, Mouth dryness, Runny nose, Fear or anxiety, Congested nose; 6. Did you feel any air leakage from the mask last night ?; 7. Was it hard keeping the mask on while sleeping?; 8. Are you prepared to use the CPAP machine as a therapy daily?

Secondary Outcome Measures

Name	Time	Method
Changes in sleep structure compared to the diagnostic night	two night	Refine the sleep structure with the usage of the device, the count of Apnea/Hypopnea index, number of arousals, number of desaturations

Trial Locations

Locations (1)

King Abdulaziz University Hospital; 🇸🇦 Jeddah, Western, Saudi Arabia