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Improvement in night sleep duration and the effect on diabetes in pregnancy

Eye-masks and earplugs to improve night sleep duration in pregnancy and the effect on the oral glucose tolerance test: a randomized trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN17526076
Enrollment
240
Registered
2021-07-14
Start date
2021-07-19
Completion date
Unknown
Last updated
2026-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glucose tolerance in pregnancy Pregnancy and Childbirth

Interventions

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 (PSQ

Sponsors

University Malaya Medical Centre
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 40 Years

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

Malaysia

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Jul 23, 2026