Parkinson Disease Clinical Trial
Official title:
The Heads-Up Trial: Sleeping in a Head-Up Tilt Position to Alleviate Orthostatic Hypotension, Supine Hypertension and Nocturia in Parkinson's Disease
Verified date | November 2023 |
Source | Radboud University Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Autonomic dysfunction is common and often underrecognized in Parkinson's disease (PD). Orthostatic hypotension (OH) affects up to a third of PD patients and often coincides with supine hypertension. This co-occurrence complicates pharmacological treatment as treatment of one can negatively affect the other. Head-up tilt sleeping (HUTS) could improve both. This phase II randomized controlled trial (RCT) aims to investigate the efficacy and tolerability of this understudied intervention, leading to optimal implementation strategies.
Status | Active, not recruiting |
Enrollment | 50 |
Est. completion date | June 2024 |
Est. primary completion date | June 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Orthostatic hypotension defined as a systolic BP decrease of =20 mmHg, or a diastolic decrease of =10 mmHg, within 3 min after changing from a supine to standing position OR mean standing BP of =75 mmHg (marker for symptomatic orthostatic hypotension). In patients with supine hypertension, a decrease in systolic BP of = 30 mmHg is required; - Orthostatic intolerance: direct complaints (dizziness, blurry vision, etc.) and/or indirect signs (falls or freezing episodes that relate to postural challenge); - Supine hypertension defined as a systolic BP of =140 mmHg, and/or diastolic of =90 mmHg, after 5 min of supine rest; - Idiopathic PD or parkinsonism (multiple system atrophy, progressive supranuclear palsy, corticobasal degeneration, vascular parkinsonism and Lewy body dementia); - Ability to walk (with or without a walking aid), as subjectively determined by the researcher; - Stable medication regimens for orthostatic hypotension and supine hypertension during the trial; Exclusion Criteria: - Inability to follow instructions and complete questionnaires, as assessed by the researcher; |
Country | Name | City | State |
---|---|---|---|
Netherlands | Leiden University Medical Center | Leiden | Zuid Holland |
Netherlands | Radboudumc | Nijmegen | Gelderland |
Lead Sponsor | Collaborator |
---|---|
Radboud University Medical Center | Leiden University Medical Center, Michael J. Fox Foundation for Parkinson's Research |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Timed up and go test (TUG) | Measurement of the time that the participant takes to rise from a chair, walk three meters, turn around 180 degrees, walk back to the chair, and sit down while turning 180 degrees | Pre-intervention (day before week 1, T0) and post-intervention (day after week 7,T1) | |
Other | Symptoms of Parkinson's disease | Movement disorders society unified disease rating scale (MDS-UPDRS). Scores range from 0 to 199, with a higher score indicating a more severe impairment related to Parkinson's disease. | Pre-intervention (day before week 1, T0) and post-intervention (day after week 7,T1) | |
Other | Quality of sleep | Pittsburgh Sleep Quality Index (PSQI). Score ranges from 0 to 21, with 21 indicating a worse sleep quality. | Pre-intervention (day before week 1, T0) and post-intervention (day after week 7,T1) | |
Other | Fear of falling | Falls Efficacy Scale (FES). Scores ranges from 16 to 67, with a higher score meaning a worse fear of falling. | Pre-intervention (day before week 1, T0) and post-intervention (day after week 7,T1) | |
Other | Subjective level of physical activity | Longitudinal Aging Study Amsterdam (LASA) Physical Activity Questionnaire (LAPAQ). Score corresponds to time spend doing physical activities. A higher score indicates a more active last two weeks. | Pre-intervention (day before week 1, T0) and post-intervention (day after week 7,T1) | |
Other | Cardiovascular autonomic symptoms | Selected cardiovascular questions from the Scales for Outcomes in Parkinson's Disease - Autonomic Dysfunction (SCOPA-AUT). Scored 0 to 9, a worse score means more symptoms of orthostatic hypotension. | Pre-intervention (day before week 1, T0) and post-intervention (day after week 7,T1) | |
Other | Experienced quality of life | Quality of life questionnaire: the Parkinson's disease questionnaire (PDQ-39). Scores range from 0 to 100, with a higher score indicating a worse quality of life. | Pre-intervention (day before week 1, T0) and post-intervention (day after week 7,T1) | |
Other | Experienced anxiety and depression | Quality of life questionnaire: the hospital anxiety and depression scale (HADS). Scores range from 0 to 21 for depression and anxiety, a score between 0-7 means no anxiety or depression, 8-14 possibility of an anxiety or depressive disorder and 15-21 likely a depressive or anxiety disorder. | Pre-intervention (day before week 1, T0) and post-intervention (day after week 7,T1) | |
Other | Mental health | Quality of life questionnaire: the Mental Health Continuum-Short Form (MHC-SF). Scores range from 0 to 70, with a higher score meaning a better emotional wellbeing. | Pre-intervention (day before week 1, T0) and post-intervention (day after week 7,T1) | |
Primary | Average overnight supine blood pressure | Average overnight supine blood pressure (mmHg) from the 24h ambulatory blood pressure measurement (ABPM) | Measured four times: in week 1, 3, 5 and 7 | |
Secondary | Daily supine blood pressure | Supine blood pressure (mmHg) measured every morning directly after awakening before getting out of bed | Daily in week 1 up to and including week 7 | |
Secondary | Orthostatic blood pressure | Standing orthostatic blood pressure test (mmHg). Measured in clinic and home-based guided by a researcher via video call. | Measured six times: in-clinic (T0; pre-intervention), in week 1, 3, 5 and 7, and in-clinic on the day after week 7 ends (T1; post-intervention) | |
Secondary | 24h ABPM parameters | 24h ABPM parameters blood pressure variability (mmHg), nocturnal blood pressure dipping (mmHg) and average daytime blood pressure (mmHg). Each of these measures will be derived from the 24 hour blood pressure measurements, and reported separately. | In week 1, 3, 5 and 7 | |
Secondary | Orthostatic tolerance | Self-reported burden of symptoms of orthostatic hypotension (Orthostatic hypotension questionnaire (OHQ)). The score ranges from 0 to 100, with a higher number meaning worse symptoms of orthostatic hypotension. | Week 1, 3, 5 and 7 | |
Secondary | Nocturia | Self-reported frequency of daytime and night time urination and impact on quality of life (International Consultation on Incontinence Questionnaire Nocturia Module (ICIQ-N)) | Week 1, 3, 5 and 7 | |
Secondary | Subjective comfort of HUTS (head up tilted sleeping) | Self-reported tolerability of the head up tilted sleeping at different angles including questions about sleep duration, sleep quality and comfort, and feeling rested in the morning. | Week 1, 3, 5 and 7 | |
Secondary | Falls | Self-reported falls and in case of a fall additional questions about the time and circumstances | Week 1, 3, 5 and 7 | |
Secondary | Overnight change in body weight | Weight (kg) difference between the evening and the morning, both measured after micturition | Daily in week 1 up to and including week 7 | |
Secondary | Nighttime urine production | Urine volume measured in a urinal (ml) | Week 1, 3, 5 and 7 | |
Secondary | Barriers and facilitators of the intervention | Structured interview | Immediately post-intervention (day after week 7, T1) |
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