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Table 2 Primary outcomes

From: Multiple N-of-1 trials to investigate hypoxia therapy in Parkinson’s disease: study rationale and protocol

Primary outcome variable

Measurement frequency

Nature and number of adverse events

Every 10 min during intervention, up to one hour post-intervention, one time next morning post-intervention

Self-reported dizziness, discomfort and stress on a ten-point scale

Every 10 min up to one hour post-intervention, one time next morning post-intervention

Number of serious or irreversible adverse events

Every 10 min, up to one hour post-intervention, one time next morning post-intervention

 

Measured continuously for safety, recorded:

- Blood pressure systolic-diastolic

Baseline and every 5 min—> 30 min post-intervention

- Heartrate

Baseline and every 5 min—> 30 min post-intervention

- Respiratory rate

Baseline and every 5 min—> 30 min post-intervention

- Oxygen saturation

Baseline and every 5 min—> 30 min post-intervention

Feasibility questionnaire (total score and subscores)

(in Supplementary Materials)

After 1st, 5th and 10th intervention