NCT00832065

Brief Summary

Obstructive Sleep Apnea Syndrome (OSAS)is a common disease and is suspected to be associated with sexual dysfunction. Our purpose is to sudy the effect of CPAP (Continuous Positive Airway Pressure) treatment on patients' sexual dysfunction by measuring testosterone levels before and after CPAP treatments.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2009

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
withdrawn

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 Start

First participant enrolled

January 1, 2009

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

January 28, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 29, 2009

Completed
7.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

August 24, 2017

Status Verified

August 1, 2017

Enrollment Period

7.6 years

First QC Date

January 28, 2009

Last Update Submit

August 22, 2017

Conditions

Sleep Apnea, ObstructiveSleep ApneaHypotestosteronism

Keywords

Sleep Apnea SyndromeSleep ApneaCPAPLow testosteroneSexual Dysfunction

Outcome Measures

Primary Outcomes (1)

  • Correlation between low free testosterone levels, sexual dysfunction and Obstructive Sleep Apnea before and after treatment with CPAP. Free testosterone levels and its affect with CPAP treatment

    3 months

Secondary Outcomes (1)

  • Sexual Function Assessments. Confirmation of a link between OSAS, elevated CRP levels, and low testosterone.

    3 months

Study Arms (1)

Patients With Sleep Apnea and Low Testosterone

Adult male patients between 18-70 years of age with nely diagnosed OSAS documented by all night polysomnography(PSG)

Eligibility Criteria

Age18 Years - 70 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients from the departments of Pulmonary and Critical Care and Endocrinology Lahey Clinic

You may qualify if:

  • Adult males ages 18-70 with newly diagnosed OSAS documented by all-night polysomnography (PSG)

You may not qualify if:

  • Currently on testosterone replacement therapy
  • Prior known cause of erectile dysfunction
  • Patients with prior treatment of erectile dysfunction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Lahey Clinic, Inc.

Burlington, Massachusetts, 01805, United States

Location

Lahey Clinic Northshore

Peabody, Massachusetts, 01960, United States

Location

Related Publications (6)

  • Karacan I, Karatas M. Erectile dysfunction in sleep apnea and response to CPAP. J Sex Marital Ther. 1995 Winter;21(4):239-47. doi: 10.1080/00926239508414643.

    PMID: 8789505BACKGROUND

  • Bratel T, Wennlund A, Carlstrom K. Pituitary reactivity, androgens and catecholamines in obstructive sleep apnoea. Effects of continuous positive airway pressure treatment (CPAP). Respir Med. 1999 Jan;93(1):1-7. doi: 10.1016/s0954-6111(99)90068-9.

    PMID: 10464840BACKGROUND

  • Grunstein RR, Handelsman DJ, Lawrence SJ, Blackwell C, Caterson ID, Sullivan CE. Neuroendocrine dysfunction in sleep apnea: reversal by continuous positive airways pressure therapy. J Clin Endocrinol Metab. 1989 Feb;68(2):352-8. doi: 10.1210/jcem-68-2-352.

    PMID: 2493027BACKGROUND

  • Goncalves MA, Guilleminault C, Ramos E, Palha A, Paiva T. Erectile dysfunction, obstructive sleep apnea syndrome and nasal CPAP treatment. Sleep Med. 2005 Jul;6(4):333-9. doi: 10.1016/j.sleep.2005.03.001.

    PMID: 15946896BACKGROUND

  • Hoekema A, Stel AL, Stegenga B, van der Hoeven JH, Wijkstra PJ, van Driel MF, de Bont LG. Sexual function and obstructive sleep apnea-hypopnea: a randomized clinical trial evaluating the effects of oral-appliance and continuous positive airway pressure therapy. J Sex Med. 2007 Jul;4(4 Pt 2):1153-62. doi: 10.1111/j.1743-6109.2006.00341.x. Epub 2006 Nov 1.

    PMID: 17081222BACKGROUND

  • Luboshitzky R, Lavie L, Shen-Orr Z, Lavie P. Pituitary-gonadal function in men with obstructive sleep apnea. The effect of continuous positive airways pressure treatment. Neuro Endocrinol Lett. 2003 Dec;24(6):463-7.

    PMID: 15073577BACKGROUND

MeSH Terms

Conditions

Sleep Apnea, ObstructiveSleep Apnea SyndromesSexual Dysfunction, Physiological

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesGenital DiseasesUrogenital Diseases

Study Officials

  • Akmal Sarwar, M.D.

    Lahey Clinic, Inc.

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2009

First Posted

January 29, 2009

Study Start

January 1, 2009

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

August 24, 2017

Record last verified: 2017-08

Locations

US(2)