Back to resultsHead-up Tilt Sleeping to Alleviate Orthostatic Hypotension, Supine Hypertension and Nocturia in Parkinson's Disease
Primary Purpose
Parkinson Disease, Parkinsonism
Status
Recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Head-up tilt sleeping
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease focused on measuring Parkinson's disease, Orthostatic hypotension, Supine hypertension, Autonomic dysfunction
Eligibility Criteria
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;
- 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;
Sites / Locations
- RadboudumcRecruiting
- Leiden University Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Intervention group
Delayed intervention group
Arm Description
At T0, in-clinic inclusion, we will record basic characteristics and several questionnaires, we will also perform a short tilt-table-test and standing blood pressure (BP) test. Intake is followed by one week of horizontal sleeping for baseline home-based BP measurements. Participants in the intervention group will then sleep in a head-up tilt position for two weeks each in angles 6°, 12° and 18°. At the second and final in-clinic meeting, at T1, measurements done at T0 will be repeated, complemented with an assessment of barriers and facilitators of HUTS. During HUTS daily BP measurements will be done, and data will be collected on orthostatic tolerance, nighttime urine production, subjective comfort of HUTS, falls.
Follows the same structure as the intervention group, but starts with a HUTS placebo angle of 1° for two weeks, followed by two intervention angles of 6° and 12° for two weeks each. The 1°-angle serves as the control intervention.
Outcomes
Primary Outcome Measures
Average overnight supine blood pressure
Average overnight supine blood pressure (mmHg) from the 24h ambulatory blood pressure measurement (ABPM)
Secondary Outcome Measures
Daily supine blood pressure
Supine blood pressure (mmHg) measured every morning directly after awakening before getting out of bed
Orthostatic blood pressure
Standing orthostatic blood pressure test (mmHg). Measured in clinic and home-based guided by a researcher via video call.
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.
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.
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))
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.
Falls
Self-reported falls and in case of a fall additional questions about the time and circumstances
Overnight change in body weight
Weight (kg) difference between the evening and the morning, both measured after micturition
Nighttime urine production
Urine volume measured in a urinal (ml)
Barriers and facilitators of the intervention
Structured interview
Full Information
NCT ID
NCT05551377
First Posted
September 7, 2022
Last Updated
June 6, 2023
Sponsor
Radboud University Medical Center
Collaborators
Leiden University Medical Center, Michael J. Fox Foundation for Parkinson's Research
1. Study Identification
Unique Protocol Identification Number
NCT05551377
Brief Title
Head-up Tilt Sleeping to Alleviate Orthostatic Hypotension, Supine Hypertension and Nocturia in Parkinson's Disease
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 18, 2023 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Radboud University Medical Center
Collaborators
Leiden University Medical Center, Michael J. Fox Foundation for Parkinson's Research
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
Autonomic dysfunction is common and often underrecognized in Parkinson's disease (PD). Orthostatic hypotension (OH) affects up to a third of PD patients and about half of them also exhibit supine hypertension. In current clinical practice both are undertreated. The common co-occurrence of OH and supine hypertension complicates pharmacological treatment as improvement of one can be accomplished only at the expense of the other. Head-up tilt sleeping (HUTS) is the only intervention known that could improve both. The concept of HUTS is based on several small-scale observational studies and expert opinion. Although HUTS has been proposed as an effective and even first choice non-pharmacological treatment for OH for over three decades, it is often not advised to patients because of lack of evidence on its effectiveness and on how to implement it. The Heads-Up trial is a multicenter home-based double-blind phase II RCT. The study aims to investigate the efficacy and tolerability of HUTS, leading to optimal implementation strategies of HUTS to treat orthostatic hypotension and supine hypertension.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease, Parkinsonism
Keywords
Parkinson's disease, Orthostatic hypotension, Supine hypertension, Autonomic dysfunction
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants are divided into two groups, the intervention and control (delayed intervention) group.
Masking
ParticipantInvestigator
Masking Description
Both the investigator and the participants are blinded to treatment allocation.
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
At T0, in-clinic inclusion, we will record basic characteristics and several questionnaires, we will also perform a short tilt-table-test and standing blood pressure (BP) test. Intake is followed by one week of horizontal sleeping for baseline home-based BP measurements. Participants in the intervention group will then sleep in a head-up tilt position for two weeks each in angles 6°, 12° and 18°. At the second and final in-clinic meeting, at T1, measurements done at T0 will be repeated, complemented with an assessment of barriers and facilitators of HUTS. During HUTS daily BP measurements will be done, and data will be collected on orthostatic tolerance, nighttime urine production, subjective comfort of HUTS, falls.
Arm Title
Delayed intervention group
Arm Type
Other
Arm Description
Follows the same structure as the intervention group, but starts with a HUTS placebo angle of 1° for two weeks, followed by two intervention angles of 6° and 12° for two weeks each. The 1°-angle serves as the control intervention.
Intervention Type
Other
Intervention Name(s)
Head-up tilt sleeping
Intervention Description
Whole-body head-up tilt sleeping (HUTS) will be carried out in three different angles, each for the duration of two weeks. Prior to the first angle the participant will sleep in a horizontal position for 1 week. The different angles will be installed using a wedge between the mattress and bed frame.
Primary Outcome Measure Information:
Title
Average overnight supine blood pressure
Description
Average overnight supine blood pressure (mmHg) from the 24h ambulatory blood pressure measurement (ABPM)
Time Frame
Measured four times: in week 1, 3, 5 and 7
Secondary Outcome Measure Information:
Title
Daily supine blood pressure
Description
Supine blood pressure (mmHg) measured every morning directly after awakening before getting out of bed
Time Frame
Daily in week 1 up to and including week 7
Title
Orthostatic blood pressure
Description
Standing orthostatic blood pressure test (mmHg). Measured in clinic and home-based guided by a researcher via video call.
Time Frame
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)
Title
24h ABPM parameters
Description
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.
Time Frame
In week 1, 3, 5 and 7
Title
Orthostatic tolerance
Description
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.
Time Frame
Week 1, 3, 5 and 7
Title
Nocturia
Description
Self-reported frequency of daytime and night time urination and impact on quality of life (International Consultation on Incontinence Questionnaire Nocturia Module (ICIQ-N))
Time Frame
Week 1, 3, 5 and 7
Title
Subjective comfort of HUTS (head up tilted sleeping)
Description
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.
Time Frame
Week 1, 3, 5 and 7
Title
Falls
Description
Self-reported falls and in case of a fall additional questions about the time and circumstances
Time Frame
Week 1, 3, 5 and 7
Title
Overnight change in body weight
Description
Weight (kg) difference between the evening and the morning, both measured after micturition
Time Frame
Daily in week 1 up to and including week 7
Title
Nighttime urine production
Description
Urine volume measured in a urinal (ml)
Time Frame
Week 1, 3, 5 and 7
Title
Barriers and facilitators of the intervention
Description
Structured interview
Time Frame
Immediately post-intervention (day after week 7, T1)
Other Pre-specified Outcome Measures:
Title
Timed up and go test (TUG)
Description
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
Time Frame
Pre-intervention (day before week 1, T0) and post-intervention (day after week 7,T1)
Title
Symptoms of Parkinson's disease
Description
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.
Time Frame
Pre-intervention (day before week 1, T0) and post-intervention (day after week 7,T1)
Title
Quality of sleep
Description
Pittsburgh Sleep Quality Index (PSQI). Score ranges from 0 to 21, with 21 indicating a worse sleep quality.
Time Frame
Pre-intervention (day before week 1, T0) and post-intervention (day after week 7,T1)
Title
Fear of falling
Description
Falls Efficacy Scale (FES). Scores ranges from 16 to 67, with a higher score meaning a worse fear of falling.
Time Frame
Pre-intervention (day before week 1, T0) and post-intervention (day after week 7,T1)
Title
Subjective level of physical activity
Description
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.
Time Frame
Pre-intervention (day before week 1, T0) and post-intervention (day after week 7,T1)
Title
Cardiovascular autonomic symptoms
Description
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.
Time Frame
Pre-intervention (day before week 1, T0) and post-intervention (day after week 7,T1)
Title
Experienced quality of life
Description
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.
Time Frame
Pre-intervention (day before week 1, T0) and post-intervention (day after week 7,T1)
Title
Experienced anxiety and depression
Description
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.
Time Frame
Pre-intervention (day before week 1, T0) and post-intervention (day after week 7,T1)
Title
Mental health
Description
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.
Time Frame
Pre-intervention (day before week 1, T0) and post-intervention (day after week 7,T1)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amber van der Stam, MSc
Phone
+31 6 29677748
Email
Amber.vanderStam@radboudumc.nl
First Name & Middle Initial & Last Name or Official Title & Degree
Nienke de Vries, PhD
Phone
+31 6 29677748
Email
Nienke.deVries@radboudumc.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roland D Thijs, MD, PhD
Organizational Affiliation
Leiden University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Radboudumc
City
Nijmegen
State/Province
Gelderland
ZIP/Postal Code
6500 HB
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bas Bloem, MD, PhD
Facility Name
Leiden University Medical Center
City
Leiden
State/Province
Zuid Holland
ZIP/Postal Code
2333 ZA
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roland Thijs, MD, PhD
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Relevant and anonymized research data will be shared in the validated research database DANS Easy (Data Archiving and Networked Services). It will also be shared with the funding foundation (MJFF).
IPD Sharing Time Frame
Study protocol and statistical analysis plan are shared with the funding foundation prior to the onset of the study. After completion of the measurements and analysis we will share the clinical study report with the funding foundation and place relevant and anonymized data on the DANS Easy database.
IPD Sharing Access Criteria
Access to the data is restricted, meaning that researchers who are interested in re-use of the data are asked to contact the central contact person for permission. Approval is given after a signed agreement.
Learn more about this trial
Head-up Tilt Sleeping to Alleviate Orthostatic Hypotension, Supine Hypertension and Nocturia in Parkinson's Disease
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