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

ISRCTN ISRCTN50371534
DOI https://doi.org/10.1186/ISRCTN50371534
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

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

Study designParallel-arm randomized control trial design
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Home, Hospital
Study typePrevention
Participant information sheet 43170_PIS_v1.0_14Dec2022.pdf
Scientific titleEye-masks and earplugs as sleep aids to reduce blood pressure in pregnancy: A randomised controlled trial
Study hypothesisEye 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
ConditionPre-hypertension in late pregnancy in mothers with sleep deprivation
InterventionThis 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 typeDevice
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Commercially available sleep aids (eye masks and ear plugs), actigraph watch (wGT3X-BT)
Primary outcome measure1. 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
Secondary outcome measuresMaternal 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
Overall study start date01/11/2022
Overall study end date06/03/2024

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexFemale
Target number of participants140 participants
Participant inclusion criteria1. 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
Participant exclusion criteria1. 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
Recruitment start date07/03/2023
Recruitment end date28/06/2023

Locations

Countries of recruitment

  • Malaysia

Study participating centre

University Malaya Medical Centre
Jln Profesor Diraja Ungku Aziz
Lembah Pantai
Kuala Lumpur
59100
Malaysia

Sponsor information

University Malaya Medical Centre
Hospital/treatment centre

Department of Obstetrics and Gynaecology
Jln Profesor Diraja Ungku Aziz
Lembah Pantai
Kuala Lumpur
59100
Malaysia

Phone +603-79494422
Email ummc@ummc.edu.my
Website https://www.ummc.edu.my
ROR logo "ROR" https://ror.org/00vkrxq08

Funders

Funder type

Hospital/treatment centre

Universiti Malaya Medical Centre
Government organisation / Universities (academic only)
Alternative name(s)
University of Malaya, University Malaya, Malayan University, UM
Location
Malaysia

Results and Publications

Intention to publish date01/10/2024
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryData sharing statement to be made available at a later date
Publication and dissemination planPlanned publication in a high-impact peer reviewed journal
IPD sharing planThe 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

Additional files

43170_PIS_v1.0_14Dec2022.pdf

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).