N/A
Completed N=65
Sleep Duration and Blood Pressure During Sleep
Blood Pressure · Hypertension · elevated blood pressure · Sleep
Source: ClinicalTrials.gov NCT05062161 ↗
Enrolled (actual)
65
Serious AEs
0.0%
Results posted
Oct 2025
Primary outcomePrimary: Mean Sleep Systolic Blood Pressure (BP) at Baseline and 8 Weeks — 100.8; 100.0; 101.4; 102.3 mmHg
Summary
The purpose of this study is to examine the impact that sleep duration has on blood pressure (BP) levels during sleep. The investigator will examine the effect of an 8-week sleep hygiene/extension intervention vs. control on sleep BP.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Sleep Systolic Blood Pressure (BP) at Baseline and 8 Weeks |
100.8; 100.0; 101.4; 102.3 | — |
| PRIMARY Mean Sleep Diastolic Blood Pressure (BP) at Baseline and 8 Weeks |
58.6; 57.9; 60.0; 60.1 | — |
| SECONDARY Mean Awake Systolic Blood Pressure (BP) at Baseline and 8 Weeks |
— | — |
| SECONDARY Mean Awake Diastolic Blood Pressure (BP) at Baseline and 8 Weeks |
— | — |
| SECONDARY Mean 24-hour Systolic Blood Pressure (BP) at Baseline and 8 Weeks |
— | — |
| SECONDARY Mean 24-hour Diastolic Blood Pressure (BP) at Baseline and 8 Weeks |
— | — |
| SECONDARY 24-hour High Frequency Heart Rate Variability |
— | — |
Eligibility Criteria
Inclusion Criteria
- English speaking adults
- Age 18 and older
- Sleep duration 50 cm
- Lymphedema of the arm or unable to wear ABPM device for 24 hours or wrist actigraphy for 8 weeks
- End-stage renal disease (ESRD) on dialysis
- Unreliable internet or phone/text access
- High risk of Obstructive Sleep Apnea (OSA) (using the Berlin Questionnaire or diagnosis of OSA or use continuous positive airway pressure device)
- High risk of insomnia (using the Insomnia Severity Index), or a known prior history of insomnia, and/or use of prescription sleep aides
- High risk of depression (using the Patient Health Questionnaire Depression Scale: PHQ-8)
- Perimenopausal women who have hot flashes (using the Menopause Rating Scale (MRS) questionnaire, administered only to females age 45-65)
- Plan to travel out of state and/or internationally during the study period
Data sourced from ClinicalTrials.gov (NCT05062161). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.