Sleep Apnea
Conditions
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.
Interventions
DEVICEContinuous 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) 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
Sponsors
King Abdulaziz University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Saudi Arabia
Contacts
Primary ContactSiraj O Wali, Professor
Outcome results
None listed