Sleep Disturbances in the 2nd and 3rd Trimester

NCT03763071 | Completed

• 1 other identifier: 2018-1
• Study Type: observational
• Target: 683
• Locations: 1 country
• Sites: 1

Brief Summary

Sleep disorders and disturbances are mostly underestimated in clinical practice. Moreover, this problem is generally neglected by the pregnant themselves. Today, it is important to underline any problem that may have an affect to improve the quality of life during pregnancy. This study assesses the sleep quality, insomnia patterns and obstructive sleep apnea in the second and third trimesters of pregnancy.

Conditions

Sleep Initiation and Maintenance Disorders; Sleep; Sleep Apnea; Sleep Disorder; Sleep Disturbance; Sleep Apnea, Obstructive; Pregnancy Related; Pregnancy

Outcome Measures

Primary Outcomes (4)

• Pittsburgh Sleep Quality Index (PSQI)

  The order of the PSQI items has been modified from the original order in order to fit the first 9 items (which are the only items that contribute to the total score) on a single page. Item 10, which is the second page of the scale, does not contribute to the PSQI score. In scoring the PSQI, seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality.

  Through study completion, an average of 39 weeks

• Berlin Questionnaire

  The questionnaire consists of 3 categories related to the risk of having sleep apnea. Patients can be classified into High Risk or Low Risk based on their responses to the individual items and their overall scores in the symptom categories. High Risk: if there are 2 or more categories where the score is positive. Low Risk: if there is only 1 or no categories where the score is positive.

  Through study completion, an average of 39 weeks

• Stop-Bang questionnaire

  This questionnaire evaluates the risk of sleep apnea. Low risk of OSA: Yes to 0-2 questions Intermediate risk of OSA: Yes to 3-4 questions High risk of OSA: Yes to 5-8 questions or Yes to 2 or more of 4 STOP questions + male gender or Yes to 2 or more of 4 STOP questions + BMI \> 35 kg/m2 or Yes to 2 or more of 4 STOP questions + neck circumference.

  Through study completion, an average of 39 weeks

• Insomnia Severity Index (ISI)

  ISI measures the insomnia and related parameters. Scoring and Interpretation as follows: Add the scores for all seven items (questions 1 + 2 + 3 + 4 + 5 +6 + 7) will give the total score. Total score categories: 0-7 = No clinically significant insomnia 8-14 = Subthreshold insomnia 15-21 = Clinical insomnia (moderate severity) 22-28 = Clinical insomnia (severe)

  Through study completion, an average of 39 weeks

Study Arms (1)

Participants

Pregnant women in the 2nd or 3th trimester Patient-reported scales to measure sleep disorders

Other: Patient-reported scales to measure sleep disorders

Interventions

Patient-reported scales to measure sleep disorders OTHER

Patient-reported scales to measure sleep disorders include below mentioned scales: Pittsburgh Sleep Quality Index; measures the quality of sleep Berlin Questionnaire; measures the obstructive sleep apnea Stop-Bang questionnaire; measures the obstructive sleep apnea Insomnia Severity Index; measures the insomnia and related parameters

Participants

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Volunteered, low-risk, uncomplicated singleton pregnancy

You may qualify if:

• nd or 3rd trimester of pregnancy

You may not qualify if:

• Complicated pregnancy
• Multiple pregnancy
• Known sleep disorder

Sponsors & Collaborators

• Bartin State Hospital: lead

Study Sites (1)

Bartin State Hospital

Bartın, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Sleep Apnea Syndromes; Sleep Wake Disorders; Parasomnias; Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Nervous System Diseases; Mental Disorders; Apnea; Respiration Disorders; Respiratory Tract Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Murat Yassa, MD

  Bartin State Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: November 23, 2018
• First Posted: December 4, 2018
• Study Start: December 7, 2018
• Primary Completion: April 8, 2020
• Study Completion: April 29, 2020
• Last Updated: January 26, 2021

Record last verified: 2021-01

Locations

TU (1)