Eye-masks and earplugs as sleep aids to reduce blood pressure in pregnancy

ISRCTN	ISRCTN50371534
DOI	https://doi.org/10.1186/ISRCTN50371534
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	Nil known
Sponsor	University Malaya Medical Centre
Funder	Universiti Malaya Medical Centre

Submission date: 06/02/2023
Registration date: 17/02/2023
Last edited: 05/03/2025

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Pregnancy and Childbirth

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
Short sleep duration in pregnancy is common and tends to worsen into late pregnancy. The risk of pregnancy-induced high blood pressure increases with sleep deprivation. This study aims to evaluate the effects of the use of eye masks and earplugs as sleep aids on blood pressure in women with borderline high blood pressure and short sleep duration in late pregnancy over a one-week study period.

Who can participate?
Adult women in late pregnancy with sleep deprivation and pre-hypertension

What does the study involve?
In this study, participants will be assigned by a computer to use an eye mask and earplugs for sleep or normal care (no eye mask and earplugs). Participants will be given a wristwatch-like device (ActiGraph) to wear continuously for the week and be required to record their blood pressure in a blood pressure diary twice a day. This needs to be done before bedtime at night and after awakening in the morning using the automated blood pressure machine provided and as instructed. Participants will complete a sleep questionnaire at recruitment and at the end of the study.

What are the possible benefits and risks of participating?
The use of eye masks and earplugs may increase sleep duration but there is at present no evidence to show that pregnancy outcomes will improve. The impact of the use of an eye mask and earplugs on blood pressure in pregnancy is not established. The use of eye masks and earplugs is not expected to have any adverse effect.

Where is the study run from?
University Malaya Medical Centre (Malaysia)

When is the study starting and how long is it expected to run for?
November 2022 to March 2024

Who is funding the study?
University Malaya Medical Centre (Malaysia)

Who is the main contact?
Dr Shahira Aqilah Zulkifli, shahiraqilah@gmail.com (Malaysia)

Contact information

Dr Shahira Aqilah Zulkifli
Principal investigator

Medical Officer Obstetrics and Gynaecology Department
University Malaya Medical Centre
Kuala Lumpur
59100
Malaysia

Phone	+6012 3307720
Email	shahiraqilah@gmail.com

Prof Tan Peng Chiong
Scientific

Consultant in Obstetrics and Gynaecology Department
University Malaya Medical Centre
Kuala Lumpur
59100
Malaysia

Phone	+603 79492049
Email	tanpengchiong@yahoo.com

Prof Mukhri Hamdan
Scientific

Consultant in Obstetrics and Gynaecology Department
University Malaya Medical Centre
Kuala Lumpur
59100
Malaysia

Phone	+6012 3615253
Email	mukhri@ummc.edu.my

Study information

Primary study design	Interventional
Study design	Parallel-arm randomized control trial design
Secondary study design	Randomised controlled trial
Participant information sheet	43170_PIS_v1.0_14Dec2022.pdf
Scientific title	Eye-masks and earplugs as sleep aids to reduce blood pressure in pregnancy: A randomised controlled trial
Study objectives	Eye masks and earplugs as sleep aids will reduce blood pressure in women with pre-hypertension (suboptimal blood pressure) and short night sleep duration in late pregnancy.
Ethics approval(s)	Approved 18/01/2023, Medical Research Ethics Committee, University Malaya Medical Centre, (Lembah Pantai, 59100 Kuala Lumpur, Malaysia; +603-79493209 ext 2251; ummc-mrec@ummc.edu.my), ref: 20221215-11811
Health condition(s) or problem(s) studied	Pre-hypertension in late pregnancy in mothers with sleep deprivation
Intervention	This is an interventional randomized controlled study in which participants will be assigned by a computer (only revealed after the opening of an envelope after mothers consent to participate) into two groups for seven consecutive days of the study: 1. Wear an eye mask and ear plugs as sleep aids and wear an actigraphy watch 2. No sleep aids and wear an actigraphy watch At recruitment participants will complete a sleep questionnaire. During the one-week study period, participants will need to: 1. Use the eye mask and earplugs for sleep OR normal care (no eye mask and earplugs) for sleep, as randomly allocated 2. Wear the wristwatch-like device (ActiGraph) continuously for the week, most importantly during sleep (night sleep as well as daytime naps) 3. Record their sleep in a Sleep diary as the time they go to bed to sleep and the time they wake to get out of bed for both night sleep as well as any daytime naps. This information is needed by the actigraphy software to work out your sleep duration when in bed for sleep. 4. Record their blood pressure in a Blood Pressure diary twice a day, before bedtime at night and after awakening in the morning using the automated blood pressure machine provided and as instructed After the one-week study period, participants will need to: 1. Return the Actigraph device for sleep data to be downloaded and analysed 2. Return the Sleep and Blood Pressure diaries 3. Complete the sleep questionnaire again
Intervention type	Device
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Commercially available sleep aids (eye masks and ear plugs), actigraph watch (wGT3X-BT)
Primary outcome measure(s)	1. Systolic blood pressure measured using an automated blood pressure machine from recruitment to during the intervention period 2. Diastolic blood pressure measured using an automated blood pressure machine from recruitment to during the intervention period
Key secondary outcome measure(s)	Maternal outcome: 1. Mean arterial pressure measured using an automated blood pressure machine from recruitment to during the intervention period 2. Pregnancy-induced hypertension (systolic BP ≥ 140 and/or diastolic ≥ 90 mmHg) on 2 occasions at least 4 hours measured using an automated blood pressure machine apart during the intervention period 3. Actigraphy derived-night sleep duration measured using data recorded in the watch app during the intervention period 4. Sleep quality measured using the Pittsburgh Sleep Quality Index (PSQI) at recruitment and at the end of the intervention period 5. Pregnancy outcome measured using data recorded in patient medical notes: 5.1. Labour induction 5.2. Mode of delivery 5.3. Peri-delivery blood loss Neonatal outcome measured using data recorded in patient medical notes after birth: 1. Birth weight 2. Cord arterial blood pH and base excess 3. Health evaluation measured using APGAR scoring at 1 and 5 minutes after birth 4. Neonatal intensive care unit (NICU) admission
Completion date	06/03/2024

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target sample size at registration	140
Key inclusion criteria	1. Blood pressure within suboptimal/pre-hypertension range (systolic 120-139 and/or diastolic 80-89 mmHg) 2. Self-reported sleep of less than 6 hours 3. Gestation 34-36 weeks 4. Age more or equal to 18 years old 5. Singleton pregnancy
Key exclusion criteria	1. Anticipated delivery in the next week 2. Significant visual and/or hearing impairment 3. On antihypertensives for gestational hypertension or chronic hypertension 4. Known sleep disorders: Chronic insomnia, sleep apnoea 5. Known psychiatric disorders: Depression, schizophrenia etc. 6. Known major medical disorders: Diabetic Mellitus type 1 or 2, SLE, thyroid disorders, epilepsy, heart diseases etc. 7. Inability/unwillingness to use an eye mask and earplugs 8. Inability/unwillingness to use ActiGraph wGT3X-BT device 9. BMI >35 10. Active smoker 11. Current alcohol consumption 12. Multipara with co-sleeping child/children 13. Night shift workers 14. Night caretaker of other family members 15. Gross fetal anomalies 16. Intrauterine fetal death
Date of first enrolment	07/03/2023
Date of final enrolment	28/06/2023

Locations

Countries of recruitment

Malaysia

Study participating centre

University Malaya Medical Centre

Jln Profesor Diraja Ungku Aziz
Lembah Pantai
Kuala Lumpur
59100
Malaysia

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Data sharing statement to be made available at a later date
IPD sharing plan	The data sharing plans for the current study are unknown and will be made available at a later date

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	version 1.0	14/12/2022	16/02/2023	No	Yes
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Additional files

43170_PIS_v1.0_14Dec2022.pdf: Participant information sheet

Editorial Notes

05/03/2025: The following changes were made to the study record:
1. The recruitment start date was changed from 06/03/2023 to 07/03/2023.
2. The recruitment end date was changed from 01/01/2024 to 28/06/2023.
16/02/2023: Trial's existence confirmed by the Medical Research Ethics Committee of The University of Malaya Medical Centre (Malaysia).