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Table 1 Overview of study procedures

From: Study protocol for the Heads-Up trial: a phase II randomized controlled trial investigating head-up tilt sleeping to alleviate orthostatic intolerance in Parkinson’s Disease and parkinsonism

Activity

In-clinic 1

Wk1

Wk2-3

Wk4-5

Wk6-7

In-clinic 2

Informed consent

X

     

Demographics

X

     

Tilt-table and BP standing test

X

    

X

MDS-UPDRS

X

    

X

Questionnaires OHQ, PSQI, FES, selected questions from SCOPA, PDQ-39, HADS and MHC-SF

X

    

X

Timed Up and Go test

X

    

X

Average overnight and daytime BP with 24-h ABPM (4x)

 

X

X

X

X

 

Supine BP (daily, 45x)

 

X

X

X

X

 

Standing BP (guided, 4x)

 

X

X

X

X

 

Questionnaire on phone app (4x)

- OHQ

- ICIQ-N

- Number of falls

- Nocturia

- Subjective comfort of HUTS

 

X

X

X

X

 

Nocturia measurements

- Body weight (45x)

- Nighttime urine production (4x)

 

X

X

X

X

 

Interview on barriers and facilitators of HUTS

     

X

Protocol

Instructions

X

     

Sleeping horizontally

 

X

    

(Possible) Home visit to install angle

 

X

X

X

X

 

HUTS angle 1

  

X

   

HUTS angle 2

   

X

  

HUTS angle 3

    

X

 

Phone/video call with researcher

 

X

X

X

X

 

Aftercare (personalized advice)

     

X

  1. BP = blood pressure; HUTS = sleeping in head-up tilt; MDS-UPDRS = Movement Disorders Society Unified Parkinson Disease Rating Scale; OHQ = orthostatic hypotension questionnaire; PSQI: Pittsburgh sleep quality index; FES: Falls Efficacy Scale; SCOPA: SCales for Outcomes in PArkinson’s disease; PDQ: Parkinson’s disease questionnaire; HADS: Hospital anxiety and depression scale; MHC-SF: Mental Health Continuum Short Form; ICIQ-N: International Consultation on Incontinence Questionnaire Nocturia Module