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

Sleep Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05475119
• Other study ID #: 724-19
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2022
• Est. completion date: December 30, 2022

Study information

• Verified date: July 2022
• Source: King Abdulaziz University
• Contact: Siraj O Wali, Professor
• Phone: 0126408222
• Email: sowali[@]kau.edu.sa
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 30, 2022
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

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.
• 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

Locations

Country	Name	City	State
Saudi Arabia	King Abdulaziz University Hospital	Jeddah	Western

Sponsors (1)

Lead Sponsor	Collaborator
King Abdulaziz University

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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