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

NCT05475119 | Unknown DMC

• 1 other identifier: 724-19
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Apnea

Outcome Measures

Primary Outcomes (3)

• 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 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?

  two nights

Secondary Outcomes (1)

• Changes in sleep structure compared to the diagnostic night

  two night

Study Arms (1)

Participants diagnosed with Obstructive Sleep Apnea

EXPERIMENTAL

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); Device: High Flow Nasal Cannula (HFNC)

Interventions

Continuous Positive Airway Pressure (CPAP) DEVICE

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.

Participants diagnosed with Obstructive Sleep Apnea

High Flow Nasal Cannula (HFNC) DEVICE

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

Participants diagnosed with Obstructive Sleep Apnea

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• King Abdulaziz University: lead

Study Sites (1)

King Abdulaziz University Hospital

Jeddah, Western, 22230, Saudi Arabia

RECRUITING

Related Publications (1)

• Wali S, Batawi G, Bin Afeef G, Bamagoos AA, Jamal A, Kanbr O, Alshumrani R, Alhejaili F, Badr MS. The effectiveness of high-flow nasal cannula therapy in comparison with continuous positive airway pressure therapy in patients with obstructive sleep apnea: an open-label randomized crossover trial. J Clin Sleep Med. 2025 Jun 1;21(6):1023-1031. doi: 10.5664/jcsm.11640.

  PMID: 40051198 DERIVED

MeSH Terms

Conditions

Sleep Apnea Syndromes

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Siraj O Wali, Professor

  Teaching Assistant at King Abdulaziz University

  STUDY DIRECTOR

Central Study Contacts

Siraj O Wali, Professor

CONTACT

0126408222; sowali@kau.edu.sa

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Sleep Medicine and Research Center, Professor of Medicine

Study Record Dates

• First Submitted: June 22, 2022
• First Posted: July 26, 2022
• Study Start: June 1, 2022
• Primary Completion: December 1, 2022
• Study Completion: December 30, 2022
• Last Updated: July 26, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)