Inspiratory airflow limitation during sleep: its relationship to functional complaints

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2006
INTERVENTION: Following baseline assessment, participants will be randomised to the experimental condition: therapeutic CPAP (n=10) or sham CPAP (n=10). A permuted blocking procedure will be used for the randomisation assignments using two block sizes (four and six). ?Allocation concealment? from research assistants conducting outcome assessments will be done to minimise assignment bias and to attempt to maintain blinding of assessors. The study coordinator, who will not have direct contact with participants, will be responsible for implementing randomisation. Per instruction from the study coordinator, one member of the research team will prepare the CPAP device as therapeutic or sham and provide it to another member of the team (blinded) who will interface with the patients to train them in use of the CPAP and answer questions or coach compliance during the trial. Patients will receive treatment for three weeks and then return for post‐treatment assessment. The research assistant responsible for gathering pre‐ and post‐treatment data will also be blinded to experimental condition. CONDITION: Upper airway resistance syndrome ; Respiratory ; Upper airway resistance syndrome PRIMARY OUTCOME: 1. Fatigue; 2. Daytime sleepiness; 3. Sleep quality SECONDARY OUTCOME: 1. Pain; 2. Headache; 3. Gastrointestinal discomfort; 4. Metabolic risk factors; 5. Hyperarousal INCLUSION CRITERIA: 1. Physician‐confirmed diagnosis of UARS 2. Aged between 21 years or over and 65 years or under 3. Able to speak and read English 4. Ability to tolerate only one caffeinated beverage in the morning
Epistemonikos ID: e0fa7bee207abdc65bfb76f5353a36e99ae28e82
First added on: Aug 21, 2024