Clinical trial NCT03843372: High Flow Nasal Cannula for Obstructive Sleep Apnea
Official title: High Flow Nasal Cannula Compared to Continuous Positive Airway Pressure in the Treatment of Obstructive Sleep Apnea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Keywords: Continuous Positive Airway pressure
High Flow Nasal Cannula
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2019-02-18
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: All of participants will be randomly allocated into two groups as random number table. The first group will ongoing CPAP therapy in first night and high flow nasal cannula in the second night. The second group will oppositely performed high flow nasal cannula in first night and CPAP in second night.
Primary purpose: TREATMENT

Brief summary: This study compare the efficacy of high flow nasal cannula with nasal continuous positive airway pressure. All of participants will be randomized to receive one night high flow nasal cannula therapy and another night for nasal continuous positive airway pressure.

Detailed description: Obstructive sleep apnea-hypopnea syndrome (OSAHS) is a common medical condition. Nasal continuous positive airway pressure (CPAP) is mainstay of treatment for OSAHS, but CPAP has some limitations. Patient who has bulbar dysfunction and poor consciousness are contraindications for CPAP. They are also not suitable for other therapy. There are still large number of patients could not accept CPAP. Alternative treatment method transnasal high flow was developed and previous study showed moderately reduce respiratory event. It is deliver 20 L/minute constant room air by nasal cannula. Because the technical limitation, the maximal flow rate is also 20 L/minute and it limit the effectiveness.

Recently, new high flow nasal cannula(HFNC) is developed. This HFNC has already widely been used for respiratory disease. It can deliver air flow up to 60 L/mins. It is also can maintain high humidifier and adequate temperature. The every 10 L/min air flow could generate approximately 1 cmH2O positive end expiratory pressure (PEEP). The higher air flow could generate more high PEEP and may have better effect than previous HFNC, but there are no study to evaluate the efficacy in OSAHS patient. Thus, the purpose of our study is to compare the efficacy of HFNC with standard CPAP therapy.

All of the participants were randomized into two groups for minimized first night effects. All of them would receive one-night HFNC therapy and another night for CPAP titration under PSG monitoring. The duration between these two treatments was approximately one week apart. The first group underwent CPAP titration on the first night and HFNC titration on the second night. Conversely, the second group was subjected to HFNC on the first night and CPAP titration on the second night. All of the participants were asked and recorded their side effects following completion of an HFNC or CPAP.

Eligibility criteria: Inclusion Criteria:

* Apnea hypopnea index greater than 5 times per hour
* Age greater than 18 years old.

Exclusion Criteria:

* Central sleep apnea
* Hypoventilation syndrome
* Chronic obstructive airway disease
* Receive soft palate surgery or used an oral appliance
* Intolerance to transnasal high flow or CPAP
* Pregnant women
* Unstable hemodynamic state
* Eastern Cooperative Oncology Group Performance Status higher than grade 2

Primary outcomes:
measure: Apnea Hypopnea Index
timeFrame: 2 days
measure: Oxygen Desaturation Index
timeFrame: 2 days
Secondary outcomes:
measure: Total Sleep Time
timeFrame: 2 days
measure: Sleep Efficiency
timeFrame: 2days
Other outcomes:
Locations:
city: Keelung
country: Taiwan
facility: Sleep center
Study officials:
affiliation: Chang Gung Memorial Hospital, Keelung
name: Sleep center
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yu CC, Huang CY, Hua CC, Wu HP. High-flow nasal cannula compared with continuous positive airway pressure in the treatment of obstructive sleep apnea. Sleep Breath. 2022 Jun;26(2):549-558. doi: 10.1007/s11325-021-02413-0. Epub 2021 Jun 18.