The aim of this study was to compare the tiotropium Respimat Soft Mist Inhaler and the HandiHaler in terms of their effects on sleeping oxygen saturation (SaO2) and sleep quality in patients with COPD.
Patients with chronic obstructive pulmonary disease (COPD) have poor sleep quality as a result of various alterations in oxygenation parameters and sleep macro- and micro-architecture. We aimed to compare the tiotropium Respimat Soft Mist Inhaler and the HandiHaler in terms of their effects on sleeping oxygen saturation (SaO2) and sleep quality in patients with COPD. In a randomized, parallel-group trial involving 200 patients with mild to moderate COPD (resting arterial oxygen tension \>60 mmHg while awake), we compared the effects of 6 months' treatment with the two devices on sleeping SaO2 and sleep quality.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
Comparison of the effect of tiotropium delivered by the Respimat Soft Mist Inhaler versus the HandiHaler on sleeping oxygen saturation and sleep quality in patients with COPD.
Inhalation via the HandiHaler once daily
Inhalation via the Respimat once daily
Sleeping Oxygen Saturation
Mean sleeping oxygen saturation (%)
Time frame: 6 months after treatment initiation
Sleep Quality
Sleep quality, meaning the architecture of sleep (amount of the different sleep stages across the sleep episode),consists of sleep efficiency (%) (total sleep time - TST divided by the total time in bed and multiplied by 100), REM (%TST) (rapid eye movement sleep divided by TST and multiplied by 100) and NREM (%TST) (non-rapid eye movement sleep divided by TST and multiplied by 100). NORMAL RANGES Sleep efficiency: Normal is approximately 85 to 90% or higher. NREM (%TST): 75-80% REM (%TST) normally occupies about 20-25% of sleep time.
Time frame: 6 months after treatment initiation
Sleepiness
Sleepiness - Epworth Sleepiness Scale (ESS) score (range 0-24, higher values indicate worse outcome, \>10 indicates sleepiness, \>16 excessive sleepiness)
Time frame: 6 months after treatment initiation
Hospitalization Rate
Number of patients needed hospitalization
Time frame: 6 months after treatment initiation
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