NCT06906133

Brief Summary

This study aims to examine how ovarian hormone fluctuations across the menstrual cycle affect sleep patterns. Using objective sleep tracking, hormone phase assessment, and validated questionnaires, it will assess changes in sleep quality, duration, menstrual symptoms, sleepiness, chronotype, anxiety, and depression over one full cycle.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
4mo left

Started Mar 2025

Geographic Reach
1 country

2 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress79%
Mar 2025Aug 2026

Study Start

First participant enrolled

March 1, 2025

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

March 11, 2025

Completed
22 days until next milestone

First Posted

Study publicly available on registry

April 2, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2026

Expected
Last Updated

April 6, 2025

Status Verified

April 1, 2025

Enrollment Period

10 months

First QC Date

March 11, 2025

Last Update Submit

April 3, 2025

Conditions

Sleep Quality

Keywords

Objectively measured sleepSleep qualitySleep disorder breathingOvarian hormonesMoodMenstrual cycleSleep duration

Outcome Measures

Primary Outcomes (2)

  • Sleep duration

    1\. Sleep duration - calculated in hours. minutes. Sleep output is measured utilizing home sleep test (SleepImage) that is FDA cleared and EU Medical Device Regulation (CE marked) compliant sleep test calculating: Sleep Duration (SD) based on calculating the time from sleep onset (SO) to sleep conclusion (SC) in hours and minutes.

    From March 15 2025 to January 15 2026

  • Sleep quality

    2\. Sleep Quality - based on sleep quality index (SQI) on a scale of 0-100. Sleep output is measured utilizing home sleep test (SleepImage) that is FDA cleared and EU Medical Device Regulation (CE marked) compliant sleep test calculating: Sleep Quality Index (SQI) is summary index of all sleep parameters presented on a scale of 0-100.

    From March 15 2025 to January 15 2026

Secondary Outcomes (1)

  • Ovulation days

    From March 15 2025 to January 15 2026

Study Arms (2)

30 women with natural cycle

This pilot study will aim to recruit 60 women (18-40 years) to participate; 30 natural menstrual cycle/30 that use hormonal contraceptives.

Other: Urinary-hCG

30 women using hormonal contraceptives

This pilot study will aim to recruit 60 women (18-40 years) to participate; 30 natural menstrual cycle/30 that use hormonal contraceptives.

Other: Urinary-hCG

Interventions

Urinary-hCGOTHER

Ovulation days will be detected using a commercial urine test for luteinizing hormone (LH) (PREGMATE, Ovulation Midstream Test Predictor Kit; sensitivity level:25mlU/mL). Participants will be instructed to use ovulation tests, starting 5 days before the expected ovulation (day 10) and for the next 7-10 days or until the first the first positive results are detected notify the study co-ordinator and share a photo of the results. Then participants will be asked to continue using the ovulation test for 3 more days.

30 women using hormonal contraceptives30 women with natural cycle

Eligibility Criteria

Age18 Years - 36 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

This pilot study will aim to recruit 60 women (18-36 years) to participate; 30 natural menstrual cycle/30 that use hormonal contraceptives.

You may qualify if:

  • Women, 18-36 years
  • Body Mass Index (BMI) \<=35
  • Regular menstrual cycle, defined as: length of menstrual cycle 22-35 days and length of menses \<10 days.
  • Women with natural menstrual cycle (i.e., do not use any type of hormonal contraceptives) and women using contraceptives (comparison group).

You may not qualify if:

  • Previously diagnosed with:
  • Sleep apnea, clinical insomnia, restless leg syndrome, narcolepsy.
  • Shift work and trans-meridian travel during the study period.
  • Chronic atrial fibrillation or ventricular trigemini, severe uncontrolled asthma, or other pulmonary diseases.
  • Premenstrual Dysphoric Disorder (PMDD) or severe Premenstrual Syndrome (PMS).
  • Other severe medical conditions that may affect cerebral metabolism, cancer, diabetes, rheumatoid arthritis, or other chronic health conditions.
  • Severe psychiatric conditions, Major Depressive disorder, Generalized Anxiety Disorder, Bipolar Disorder, Personality Disorder, OCD, Schizophrenia.
  • Severe neurological conditions, epilepsy, traumatic brain injury, and previous neurosurgery.
  • Habitual smokers and other habitual substance abuse or dependence on substances.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Akureyri Hospital

Akureyri, IS600, Iceland

Location

University of Akureyri

Akureyri, IS600, Iceland

Location

Related Publications (7)

  • Lu M, Penzel T, Thomas RJ. Cardiopulmonary Coupling. Adv Exp Med Biol. 2022;1384:185-204. doi: 10.1007/978-3-031-06413-5_11.

    PMID: 36217085BACKGROUND

  • Chung KF, Kan KK, Yeung WF. Assessing insomnia in adolescents: comparison of Insomnia Severity Index, Athens Insomnia Scale and Sleep Quality Index. Sleep Med. 2011 May;12(5):463-70. doi: 10.1016/j.sleep.2010.09.019. Epub 2011 Apr 13.

    PMID: 21493134BACKGROUND

  • Cassioli E, Rossi E, Melani G, Faldi M, Rellini AH, Wyatt RB, Oester C, Vannuccini S, Petraglia F, Ricca V, Castellini G. The menstrual distress questionnaire (MEDI-Q): reliability and validity of the English version. Gynecol Endocrinol. 2023 Jun 19;39(1):2227275. doi: 10.1080/09513590.2023.2227275.

    PMID: 37356456BACKGROUND

  • von Elm E, Altman DG, Egger M, Pocock SJ, Gotzsche PC, Vandenbroucke JP; STROBE Initiative. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies. Lancet. 2007 Oct 20;370(9596):1453-7. doi: 10.1016/S0140-6736(07)61602-X.

    PMID: 18064739BACKGROUND

  • Alzueta E, de Zambotti M, Javitz H, Dulai T, Albinni B, Simon KC, Sattari N, Zhang J, Shuster A, Mednick SC, Baker FC. Tracking Sleep, Temperature, Heart Rate, and Daily Symptoms Across the Menstrual Cycle with the Oura Ring in Healthy Women. Int J Womens Health. 2022 Apr 8;14:491-503. doi: 10.2147/IJWH.S341917. eCollection 2022.

    PMID: 35422659BACKGROUND

  • Li DX, Romans S, De Souza MJ, Murray B, Einstein G. Actigraphic and self-reported sleep quality in women: associations with ovarian hormones and mood. Sleep Med. 2015 Oct;16(10):1217-24. doi: 10.1016/j.sleep.2015.06.009. Epub 2015 Jun 26.

    PMID: 26429749BACKGROUND

  • Pengo MF, Won CH, Bourjeily G. Sleep in Women Across the Life Span. Chest. 2018 Jul;154(1):196-206. doi: 10.1016/j.chest.2018.04.005. Epub 2018 Apr 19.

    PMID: 29679598BACKGROUND

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Chorionic Gonadotropin

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Intervention Hierarchy (Ancestors)

GonadotropinsPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPlacental HormonesPeptidesAmino Acids, Peptides, and ProteinsPregnancy ProteinsProteins

Study Officials

  • Sólveig Magnúsdóttir, MD, MSc, MBA.

    MyCardio

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2025

First Posted

April 2, 2025

Study Start

March 1, 2025

Primary Completion

December 31, 2025

Study Completion (Estimated)

August 31, 2026

Last Updated

April 6, 2025

Record last verified: 2025-04

Locations

IC(2)