None listed
Conditions
Brief summary
Background Over half of all COPD patients suffer from poor sleep quality which is a major contributor to their reduced quality of life. There is currently a lack of understanding as to the mechanisms underlying poor sleep in COPD. Our pilot data show that more severe hyperinflation is correlated with worse sleep quality in COPD. This suggests that hyperinflation is a novel target for treating poor sleep quality in COPD. Hyperinflation compromises ventilation during sleep in two ways. Firstly, hyperinflation increases the work of breathing because gas trapping imposes a pressure load that must be overcome during inspiration (intrinsic positive end-expiratory pressure, iPEEP). Secondly, hyperinflation comprises diaphragm function, which is the predominant inspiratory muscle during sleep. Half of all patients with chronic obstructive pulmonary disease (COPD) suffer from poor sleep which is a major contributor to their reduced quality of life. However, current treatments focus on sleep apnoea and therefore do not address poor sleep for the majority of COPD patients. In COPD, the destruction of lung tissue leads to gas trapping and hyperinflation, a condition in which patients breathe at abnormally high lung volumes. Hyperinflation reduces the function of the diaphragm, the predominant muscle of breathing during sleep. This means that lung function in COPD patients is particularly vulnerability during sleep. Non-invasive ventilation, in which external pressure is applied to the lung to improve breathing, may reduce hyperinflation in patients with COPD. Therefore, we will determine the effect of ventilator settings on hyperinflation and determine the effect of optimal ventilator settings on sleep quality.
Interventions
COPD patients with poor sleep will attend an initial screening visit to assess eligibility based on lung function and other sleep characteristics. Eligible participants will be invited to return to the laboratory in which they will undergo two titrations of Bilevel non-invasive ventilation. During the first titration, inspiratory pressure will be increased from 4cmH2O up to 24cmH2O, in increments of 4cmH2O. In the second titration, the ratio of inspiratory time to expiratory time will be increas
COPD patients with poor sleep will attend an initial screening visit to assess eligibility based on lung function and other sleep characteristics. Eligible participants will be invited to return to the laboratory in which they will undergo two titrations of Bilevel non-invasive ventilation. During the first titration, inspiratory pressure will be increased from 4cmH2O up to 24cmH2O, in increments of 4cmH2O. In the second titration, the ratio of inspiratory time to expiratory time will be increased from 1:2 to 1:4, with the expiratory time ratio increased in increments of 0.5. Expiratory pressure will be set at 4cmH2O during both titrations. The two Bilevel titrations will occur over a 2 hour period. Lung function will be measured at each Bilevel setting with the next step in the titration begun after completion of lung function. The titration will be performed by a researcher. Participants will then undergo two overnight polysomnography sleep studies involving either Bilevel ventilation or no breathing assistance (control) in random order. These visits will be at least 7 days apart. During the six nights prior to the sleep study with Bilevel, participants will be asked to use Bilevel at home, with adherence monitored by device analytics. The Bilevel inspiratory pressure will be set in order to reduce functional residual capacity by 15% of predicted (calculated from Visit 1) with expiratory pressure set at 4cmH2O.
Sponsors
Woolcock Institute of Medical Research
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1) Diagnosis of COPD with smoking history of >10 pack years 2) Poor sleep quality (Pittsburgh Sleep Quality Index >5) 3) Hyperinflation (functional residual capacity or residual volume >130% predicted)
Exclusion criteria
1) Hypercapneic respiratory failure 2) Respiratory pathologies other than COPD 3) Moderate-severe Obstructive Sleep Apnoea (based on polysomnogram) 4) Insomnia (based on Insomnia Severity Index questionnaire)
Outcome results
None listed