Improvement in night sleep duration and the effect on diabetes in pregnancy
| ISRCTN | ISRCTN17526076 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17526076 |
| Secondary identifying numbers | MECID.No:202157-10120 |
- Submission date
- 02/07/2021
- Registration date
- 14/07/2021
- Last edited
- 16/02/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Plain English summary of protocol
Background and study aims
Pregnancy is associated with changes in sleep structure. Both abnormally long and short duration of sleep at night will have an impact on sugar metabolism and may affect bodily functions in the long term. This study will focus on improving the duration of sleep at night and reducing the risk of developing gestational diabetes in pregnancies less than 34 weeks.
Who can participate?
Pregnant women between the age of 18 to 40 years old, who report a duration of sleep of fewer than 7 hours
What does the study involve?
The participants will be divided into two groups, the intervention group and the control group. All participants will need to fill the questionnaire before and after the study. All the participants will be provided with an ActiGraph wGT3X-BT device and a sleep diary. The intervention group will be provided with an eye mask and earplugs and need to wear them for 7 consecutive nights. After completion of 7 days, all participants regardless of the intervention group or control group will need to return the device for data retrieval and a glucose test will be performed.
What are the possible benefits and risks of participating?
The use of an eye mask and earplugs is not expected to cause any harm to the pregnancy. If proven to be effective, the use of these simple interventions such as eye masks and earplugs will improve the duration of sleep at night and reduce the risk of developing diabetes in pregnancy. This can be identified as a modifiable risk factor and thus reducing the risk of developing gestational diabetes mellitus among pregnant women who are at risk.
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?
May 2021 to September 2022
Who is funding the study?
University Malaya Medical Centre (Malaysia)
Who is the main contact?
Dr Normala Binti Mohammad Som
normala.som@ummc.edu.my
Contact information
Scientific
T.B.G 132 Kg Kuantan
Klang
41300
Malaysia
| Phone | +60 (0)164144953 |
|---|---|
| normala.som@ummc.edu.my |
Scientific
Jln Profesor Diraja Ungku Aziz, Lembah Pantai
Kuala Lumpur
59100
Malaysia
| Phone | +60 (0)177202689 |
|---|---|
| jesrine@um.edu.my |
Scientific
University of Malaya Medical Centre
UMMC
Jalan Profesor Diraja Ungku Aziz
Kuala Lumpur
59100
Malaysia
 ORCID ID |
0000-0002-5340-2201 |
|---|---|
| Phone | +60 (0)3 79492049 |
| huda.sani@ummc.edu.my |
Study information
| Study design | Single-center randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | 40113_PIS .docx |
| Scientific title | Eye-masks and earplugs to improve night sleep duration in pregnancy and the effect on the oral glucose tolerance test: a randomized trial |
| Study acronym | EMEPOG |
| Study objectives | Home use of eye masks and earplugs will increase actigraphy-derived night sleep duration among nulliparas and multiparas and this will improve the fasting and 2-hour glucose tolerance test. |
| Ethics approval(s) | Approved 01/07/2021, Medical Research Ethics Committee University of Malaya Medical Centre (Jln Professor Diraja Ungku Aziz, 50603, Wilayah Persekutuan Kuala Lumpur, Malaysia; +603 (0)7949 8473; email: not applicable), ref: 202157-10120 |
| Health condition(s) or problem(s) studied | Glucose tolerance in pregnancy |
| Intervention | The eligibility and suitability of the patient will be identified when presented to the antenatal clinic. Once identified, participants will be asked to fill in the Pittsburgh Sleep Quality Index (PSQI). The researchers will verbally counsel them regarding the trial and written consent will be obtained if they agree to participate. Participants will then be provided with the Patient Information Sheet (PIS). Participants fill in the PSQI and will be randomized into two groups (intervention group and control group). The intervention group will be provided with an eye mask, earplugs and sleep diary and the control group will be provided with a sleep diary. All participants will then be provided with the ActiGraph wGT3X-BT device and instructed on its use. The device is to be worn like a wristwatch and participants are asked to wear it continuously for 7 consecutive nights on their dominant wrist. Participants need to perform an oral glucose tolerance test (OGTT) upon returning the device and complete a modified PSQI. Participant’s details and all the necessary information will be transcribed onto the Case Report Form (CRF). |
| Intervention type | Behavioural |
| Primary outcome measure | 1. Night sleep duration measured using the Actigraph wGT3X-BT device at the end of week 1 2. Fasting blood sugar and 2-hour post glucose tolerance test measured using oral glucose tolerance test performed at the end of week 1 |
| Secondary outcome measures | 1. Actigraphy-derived Wake After Sleep Onset (WASO) and actigraphy-derived sleep efficiency measured using the Actigraph wGT3X-BT device at the end of week 1 2. Sleep satisfaction measured using the Pittsburgh Sleep Quality Index (PSQI) during recruitment, and the modified Pittsburgh Sleep Quality Index at the end of week 1 |
| Overall study start date | 06/05/2021 |
| Completion date | 14/09/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 40 Years |
| Sex | Female |
| Target number of participants | 240 |
| Total final enrolment | 240 |
| Key inclusion criteria | 1. Self-reported sleep less than 7 hours 2. Gestation less than 34 weeks 3. Singleton pregnancy 4. Aged 18 to 40 years old |
| Key exclusion criteria | 1. Inability to use eye mask and earplugs 2. Inability to use ActiGraph wGT3X-BT device 3. Pre-existing sleep disorders: chronic insomnia, sleep apnea 4. Pre-existing psychiatric disorders: depression, schizophrenia etc 5. Pre-existing medical disorders: diabetic mellitus, systemic lupus erythematosus, thyroid disorders, epilepsy, heart diseases etc 6. Active smoker 7. Current alcohol consumption 8. Multipara with co-sleeping child/children 9. Night shift workers 10. Night care-taker of other family members 11. Gross fetal anomalies 12. Intrauterine fatal death 13. Body mass index (BMI) ≥35 kg/m² |
| Date of first enrolment | 19/07/2021 |
| Date of final enrolment | 24/08/2022 |
Locations
Countries of recruitment
- Malaysia
Study participating centre
Wilayah Persekutuan Kuala Lumpur
50603
Malaysia
Sponsor information
Hospital/treatment centre
Jln Profesor Diraja Ungku Aziz, Lembah Pantai
Wilayah Persekutuan Kuala Lumpur
59100
Malaysia
| Phone | +60 (0)3 7949422 |
|---|---|
| ummc@ummc.edu.my | |
| Website | http://www.ummc.edu.my |
"ROR" |
https://ror.org/00vkrxq08 |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 31/12/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Prof. Tan Peng Chiong (pctan@um.edu.my). Individual participant data will be available, particularly, individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices). Other documents that will be available include the Trial Protocol. Data will be available beginning 3 months and ending 5 years following article publication, to investigators whose proposed use of the data has been approved by an independent review committee identified for the purpose of individual participant data meta-analysis only. Consent from participants was required and obtained. The data will be anonymously generated. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 04/08/2021 | No | Yes | ||
| Protocol file | 04/08/2021 | No | No |
Additional files
Editorial Notes
16/02/2024: IPD sharing plan and total final enrolment added.
05/12/2023: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/12/2022 to 24/08/2022.
2. The overall end date was changed from 01/01/2023 to 14/09/2022.
3. The intention to publish date was changed from 31/12/2023 to 31/12/2024.
4. The plain English summary was updated to reflect these changes.
01/08/2022: Internal review.
26/07/2022: The overall trial end date has been changed from 31/12/2022 to 01/01/2023 and the plain English summary updated accordingly.
25/07/2022: The following changes have been made:
1. The recruitment end date has been changed from 30/06/2022 to 31/12/2022.
2. The target number of participants has been changed from 260 to 240.
21/06/2022: Contact details updated.
04/08/2021: The protocol and participant information sheet were uploaded as additional files.
13/07/2021: Trial's existence confirmed by the University of Malaya Medical Centre Medical Research Ethics Committee.
