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Completed

NCT Number: NCT03763071

Sleep Disturbances in the 2nd and 3rd Trimester

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.

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Key information

Conditions

Sleep Initiation and Maintenance Disorders Apnea Dyssomnias Mental Disorders Nervous System Diseases Neurologic Manifestations Parasomnias Pathological Conditions, Signs and Symptoms Pregnancy Pregnancy Related Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Sleep Sleep Apnea Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorder Sleep Disorders, Intrinsic Sleep Disturbance Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Bartin State Hospital

Bartın, Turkey (Türkiye)

About this study

Women with uncomplicated pregnancy in the second or third trimester who apply for the routine check will be included.

Specific questionnaires will be used to measure the sleep disorders in addition to the socio-demographic measures:

Pittsburgh Sleep Quality Index, Insomnia Severity Index, Berlin Questionnaire and Stop-Bang Questionnaire.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 2nd or 3rd trimester of pregnancy

Exclusion criteria

  • Complicated pregnancy
  • Multiple pregnancy
  • Known sleep disorder

Treatment and study plan

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

Primary outcomes

  1. Pittsburgh Sleep Quality Index (PSQI)

    Time frame: Through study completion, an average of 39 weeks

    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.

  2. Berlin Questionnaire

    Time frame: Through study completion, an average of 39 weeks

    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.

  3. Stop-Bang questionnaire

    Time frame: Through study completion, an average of 39 weeks

    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.

  4. Insomnia Severity Index (ISI)

    Time frame: Through study completion, an average of 39 weeks

    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)

Sponsors and collaborators

Lead sponsor

Bartin State Hospital

Other Gov

Registry information

Official study title

Sleep Patterns and Disturbances in the Second and Third Trimester of Uncomplicated Pregnancy

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Dec 4, 2018
Registry last updated
Jan 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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