NCT06510907Completed
MBSR on Nocturnal Hypertension
Feasibility and Acceptability of Mindfulness-based Stress Reduction Program on Patients with Nocturnal Hypertension: a Pilot Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 13 Feb 2025
Brief summary (registry, in English)
Objectives: To examine the feasibility and acceptability of treating nocturnal hypertension by mindfulness-based stress reduction program (MBSR). This will provide data essential for the main trial, which will also examine the definite effectiveness of MBSR to reduce nocturnal blood pressure (BP). Hypothesis to be tested: MBSR and the current trial are acceptable and safe to patients with nocturnal hypertension; and future main trial is feasible in terms of recruitment, dropout rate and adherence to MBSR/BP measurements. Design and subjects: This pilot randomized-controlled trial will recruit 76 patients with nocturnal HT (night-time Systolic BP (SBP) during sleep 120 mmHg) and stage I hypertension (awake SBP = 135-159mmHg), as detected by ambulatory blood pressure monitoring (ABPM). Participants will be allocated in 1:1 ratio by stratified block randomization (by age and presence of mood disorder) to receive MBSR (intervention group) or usual care (control group) respectively. Instruments: ABPM/HBPM/MBSR patients' diary. Interventions: The generic 8-week MBSR will be taught by a certified MBSR teacher. Participants in MBSR arm will be asked to meditate 40 minutes every day during the interventional period. Main outcome measures: rate of recruitment/dropout/adherence to MBSR/BP measurements Data analysis and expected results: The rate of recruitment/dropout/adherence to MBSR/BP measurements will be presented. The acceptability of MBSR and the trial will also be assessed by patients' interviews. A high level of rate of recruitment, adherence to both MBSR and BP measurements and acceptability to MBSR are expected.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 76 (actual)
- First submitted
- 15 Jul 2024
- Start date
- 1 Nov 2023
- Primary completion date
- 30 Oct 2024
- Lead sponsor
- Chinese University of Hong Kong
- Diseases
- High blood pressure
- NCT number
- NCT06510907
What you commit to
- Study type: Interventional
- Participants enrolled: 76
- From 1 Nov 2023 to the primary completion date, 30 Oct 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- patients receiving ≥3 BP medications at maximal tolerated doses
- previous participation in structured mindfulness program(s) of ≥8 weeks or regular daily meditation practices
- patients who do not agree to keep the same dose of anti-HT medications during the trial period
- patients receiving anti-coagulants
Other illness
- history of dementia or psychotic illnesses
- patients with end-stage malignancies
Other
- patients with atrial fibrillation (these patients have greater blood pressure variability)
- daytime office systolic blood pressure (BP) ≥180 mmHg or diastolic BP ≥120 mmHg (regardless of nocturnal BP)
- patients with known obstructive sleep apnoea
- nocturnal worker, because they will have a reverse BP pattern to other participants
- reported sleep time of \<4 hours per day
Who the study is looking for
- diagnosed hypertension (HT) from clinical records (with or without anti-hypertensive medications)
- nocturnal HT (night-time systolic blood pressure \[SBP\] during sleep ≥120 mmHg) and stage I hypertension (daytime SBP = 135-159 mmHg), as detected by 24-hour ambulatory blood pressure monitoring (ABPM)
- no change of dose and type of anti-hypertensive(s) in the prior 2 months
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| School of public health and primary care Coordinator of this site? Confirm its status | Hong Kong | Hong Kong SAR China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.