Clinical trial NCT01116401: Impact of Hot Flashes on Sleep and Mood Disturbance
Official title: Impact of Experimentally Induced Hot Flashes on Sleep and Mood Disturbance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Menopause
Depression
Hot Flashes
Keywords: Hot Flashes
Sleep disturbance
Lupron
Menopause
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2010-05-05
Enrollment: 29
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: We plan to enroll premenopausal women in a trial investigating the impact of hot flashes developed in response to an injection of a gonadotropin-releasing hormone agonist (GnRHa), leuprolide (brand name: Lupron), on sleep disruption and mood. This study is designed to mimic the menopause transition. We will collect data on sleep disruption and mood changes to assess their relationship to the development of hot flashes.


Eligibility criteria: Inclusion Criteria:

* Women 18-45 years old
* Premenopausal
* Willingness to use barrier methods of contraception during study and after completion of study until menses resume
* Good general health

Exclusion Criteria:

* Pregnancy or currently breastfeeding
* Hot flushes
* Mid-luteal phase progesterone \<3ng/mL
* Clinically significant abnormalities in screening blood tests
* BMI \> 35 kg/m2
* Previously diagnosed osteoporosis or osteopenia
* Clinically significant depressive symptoms
* Psychiatric illness
* Sleep apnea or periodic limb movement of sleep (PLMS)
* Contraindication, hypersensitivity, or previous allergic reaction to GnRH agonists
* Current or recent use of centrally active medications
* Current or recent use of systemic hormone medications
* Night shift workers
* Current use of over-the-counter (OTC) medications that may affect hot flashes, sleep, or mood
* Abnormal vaginal bleeding
* History of any medical diseases that may put subject at risk when treated with study medication.

Primary outcomes:
measure: Percent Change in Wake After Sleep Onset (WASO)
timeFrame: baseline and 4 weeks
Secondary outcomes:
measure: Change in Montgomery-Asperg Depression Rating Scale (MADRS)
timeFrame: baseline and 4 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Hadine Joffe, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Joffe H, Crawford SL, Freeman MP, White DP, Bianchi MT, Kim S, Economou N, Camuso J, Hall JE, Cohen LS. Independent Contributions of Nocturnal Hot Flashes and Sleep Disturbance to Depression in Estrogen-Deprived Women. J Clin Endocrinol Metab. 2016 Oct;101(10):3847-3855. doi: 10.1210/jc.2016-2348. Epub 2016 Sep 28.
citation: Bianchi MT, Kim S, Galvan T, White DP, Joffe H. Nocturnal Hot Flashes: Relationship to Objective Awakenings and Sleep Stage Transitions. J Clin Sleep Med. 2016 Jul 15;12(7):1003-9. doi: 10.5664/jcsm.5936.
citation: Joffe H, Crawford S, Economou N, Kim S, Regan S, Hall JE, White D. A gonadotropin-releasing hormone agonist model demonstrates that nocturnal hot flashes interrupt objective sleep. Sleep. 2013 Dec 1;36(12):1977-85. doi: 10.5665/sleep.3244.