Sleep Disturbance in Pregnant Women in Upper Egypt

NCT03899727 | Completed

• 1 other identifier: SDUE
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Pregnant women are associated with hormonal, anatomic and mechanical changes that Change sleep patterns and quality of sleep. Several Investigators have reported Associations between sleep disturbances and hypertension, Coronary artery disease, Diabetes, and depression. Most of these associations have been established in the association with sleep disturbances

Conditions

Sleep Disturbance

Outcome Measures

Primary Outcomes (1)

• The percentage of women with sleep disturbances among overall included women

  diagnosis of sleep disturbances will depend on STOP and STOP-Bang questionnaires

  30 minutes

Study Arms (2)

Pregnant group

pregnant women in the third trimester of pregnancy

Device: Polysomnography

Non-pregnant group

middle aged women

Device: Polysomnography

Interventions

Polysomnography DEVICE

Polysomnography, also called a sleep study, is a test used to diagnose sleep disorders. Polysomnography records your brain waves, the oxygen level in your blood, heart rate and breathing, as well as eye and leg movements during the study

Non-pregnant group; Pregnant group

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients visiting out patient clinic at Women Health Hospital will be counseled to participate in our study careful history taking and examination to exclude patients who not eligible to participate in the study.

You may qualify if:

• All viable third trimester pregnancy

You may not qualify if:

• Intrauterine fetal death
• Any History of neurological, mental disorder.
• Any previous diagnosed sleep disturbances breathing disorder before pregnancy.
• Any patient with respiratory infection in the pregnancy.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Ahmed Abbas

Assiut, Cairo Governorate, 002, Egypt

Location

MeSH Terms

Conditions

Parasomnias

Interventions

Polysomnography

Condition Hierarchy (Ancestors)

Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Monitoring, Physiologic; Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: April 1, 2019
• First Posted: April 2, 2019
• Study Start: June 1, 2019
• Primary Completion: January 15, 2021
• Study Completion: March 1, 2021
• Last Updated: April 23, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)