Clinical trial NCT03212209: Comparison of CPAP Modalities for OSA Treatment
Official title: A Crossover Study Comparing Fixed Continuous Airway Positive Pressure, FLEX- PLUS and Sensawake Modalities for OSA Treatment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obstructive Sleep Apnea
Keywords: Sleep Apnea
CPAP
Lead sponsor: Associação Fundo de Incentivo à Pesquisa
Sponsor class: OTHER
Collaborators: name: Fisher and Paykel Healthcare
name: Philips Respironics
First posted: 2017-07-11
Enrollment: 50
Sex: MALE
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This is a crossover study comparing different CPAP modalities in a group of patients with moderate to severe OSA.
Primary purpose: TREATMENT

Brief summary: This is a crossover study comparing the effect of CPAP Fixed Pressure, CPAP FLEX -PLUS and Sensawake on sleep quality, adherence to treatments, and PSG parameters in patients with moderate to severe OSA.

Detailed description: Obstructive sleep apnea (OSA) is associated with behavioral, cognitive, metabolic and cardiovascular conditions. Continuous Positive Airway Pressure (CPAP) is the gold standard treatment for OSA. Despite being the most effective treatment for OSA, 46 to 83% of patients do not adhere to CPAP. New technologies for CPAP treatment have been developed in order to improve patient's comfort, adherence and effectiveness in reducing apnea, hypopneas and flow limitation events. As an example, the FLEX- PLUS technology which increases inspiratory positive pressure and decreases expiratory positive pressure would soften the rhythm of breathing. Sensawake is another technology which evaluates breathing pattern changes during CPAP therapy. When the breathing pattern suggests that patient is awake, a prompt relief in pressure is activated, like ramp feature. However, it is not clear whether CPAP FLEX- PLUS or Sensawake are superior compared with fixed pressure CPAP, in terms of polysomnographic parameters, especially flow limitation or adherence to treatment. Objective: To compare the effect of fixed pressure CPAP, CPAP FLEX- PLUS and Sensawake on sleep and compliance parameters in patients with moderate to severe OSA. Methods: Fifty male patients with moderate to severe OSA will be included in a crossover design study. All patients will use each CPAP modality for 30 days in a randomized order, namely CPAP with Fixed Pressure, Flex- PLUS and Sensawake. A week of washout period will be applied between treatments. All patients will wear the same nasal mask brand. At the end of each treatment (every 4 weeks), patients will undergo polysomnography and fill out Epworth, FOSQ, Pittsburgh questionnaires and a visual analogue scale assessing CPAP side effects and patient´s comfort. Finally, adherence to CPAP modalities will be systematically checked.

Eligibility criteria: Inclusion Criteria:

* male gender
* apnea-hypopnea index (AHI) score of ≥20 events/hour of sleep
* 30-65 years-old
* body mass index (BMI) ≤40 Kg/m²

Exclusion Criteria:

* major neurological, psychiatric, cardiac or respiratory disease
* use of psychoactive medication
* other sleep disorders
* patients referred to PSG for Bilevel, considered the need for PAP ≥ 18 cm H2O
* Previous contact with any OSA treatment.

Primary outcomes:
measure: Flow limitation
timeFrame: 4 weeks after each CPAP modality completion
Secondary outcomes:
measure: Adherence to CPAP treatment
timeFrame: 4 weeks after each CPAP modality completion
measure: Arousal index
timeFrame: 4 weeks after each CPAP modality completion
measure: Wake time after sleep onset
timeFrame: 4 weeks after each CPAP modality completion
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Evelyn Brasil
Study officials:
affiliation: AFIP - Associação de fundo e incentivo a pesquisa
name: Dalva Poyares, MD, PhD
role: STUDY_DIRECTOR
References: