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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Sleep Apnea
• Intervention / Treatment: Device: Continuous Positive Airway Pressure (CPAP); Device: High Flow Nasal Cannula (HFNC)

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 Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Siraj O Wali, Professor; Phone Number: 16045 0126408222; Email: sowali@kau.edu.sa

Study Locations

• Saudi Arabia
  • Western
    • Jeddah, Western, Saudi Arabia, 22230
      • Recruiting
      • King AbdulAziz University Hospital
      • Contact: Siraj O Wali, Professor; Phone Number: 1640 0126408222; Email: sowali@kau.edu.sa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Participants diagnosed with Obstructive Sleep Apnea; 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

Device: Continuous Positive Airway Pressure (CPAP); Continuous Positive Airway Pressure (CPAP) is a form of positive airway pressure ventilation in which a constant level of pressure greater than atmospheric pressure is continuously applied to the upper respiratory tract of an individual.; Device: High Flow Nasal Cannula (HFNC); High Flow Nasal Cannula (HFNC) is an oxygen supply system capable of delivering up to 100% humidified and heated oxygen at a flow rate of up to 60 liters per minute

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: King Abdulaziz University
• Investigators: Study Director: Siraj O Wali, Professor, Teaching Assistant at King Abdulaziz University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 30, 2022

Study Registration Dates

• First Submitted: June 22, 2022
• First Submitted That Met QC Criteria: July 24, 2022
• First Posted (Actual): July 26, 2022

Study Record Updates

• Last Update Posted (Actual): July 26, 2022
• Last Update Submitted That Met QC Criteria: July 24, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea
• Other Study ID Numbers: 724-19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: The study outcome might be shared as well as the methodology

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No