AzTrials
AzTrials

SleepPhase 4NCT02599701

Acute Effects of Gabapentin in Sleep Parameters and Hormonal Release During Sleep in Older Men

A Phase 4 study testing Gabapentin in people with Sleep, run by Associação Fundo de Incentivo à Pesquisa at 1 site in Brazil.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

The primary objective of this study is to evaluate the effects of gabapentin in sleep polysomnography parameters and in nocturnal secretion of endogenous hypothalamic-pituitary-adrenal (HPA), hypothalamic-pituitary-gonadal (HPG) and somatotropic axes hormones and basal IGF-1 in older men. Read more about this study

Who is it for?
Ages 60 years and older, men onlyHealthy volunteers can take part
Conditions the study is for
Sleep
What is being tested?
Gabapentin
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
8 participants
Where
1 siteBrazil
Study dates
Sep 2015to Dec 2015
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • Men only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 60 years old or more,
  • healthy men

Who cannot join

  • Basal Apnea-Hypopnea index (aHI)>=15
  • Restless Legs Syndrome Symptons
  • BMI less than 18.5 kg/m2 or greater than 30 kg/m2
  • Less than 30 min. of regular physical activity (at least walking inside home, etc.)
  • Plasma albumin below 3.5 mg/dL
  • Psychoactive drugs use
Show all 23Show fewer
  • Drugs with muscle anabolic potential
  • Current treatment for obesity or weight gain
  • Enteral or parenteral feeding
  • Inability to walk without assistance,
  • Loss of independence in any activity of daily living
  • Nocturia above 2 episodes
  • Smoking more than 2 cigarettes per day
  • Alcoholism (more than 2 doses a day)
  • Prior epilepsy diagnosis
  • Clinically evident atherosclerotic disease
  • Dementia
  • Depression
  • Rheumatic diseases
  • Cancer
  • Diabetes (poorly controlled, HbA1C > 7,0, requirement of insulin)
  • Thyroid dysfunction without treatment
  • Advanced stages in COPD, HF, liver or renal failure

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • Instituto do Sono

    São Paulo, São Paulo, 04024-002

Other trials in Brazil

About this study

Official title: Acute Effects of Gabapentin on Polysomnography Parameters and on Hypothalamic-pituitary-adrenal, Hypothalamic-pituitary-gonadal and Somatotropic Axes During Sleep in Older Men: a Randomized, Double-blind, Placebo-controlled Trial

The primary objective of this study is to evaluate the effects of gabapentin in sleep polysomnography parameters and in nocturnal secretion of endogenous hypothalamic-pituitary-adrenal (HPA), hypothalamic-pituitary-gonadal (HPG) and somatotropic axes hormones and basal IGF-1 in older men.

Read the detailed description

The influence of sleep variables on muscle protein anabolism is little studied, but data on the effects of slow-wave sleep and the syndrome of obstructive sleep apnea on the hypothalamic-pituitary axis indicate that interventions in the sleep structure and disorders impact on the age-related muscle loss. Thus, we propose to assess the acute effects of a drug potentially capable of increasing slow wave sleep, and consequently growth hormone release during sleep, on the physiological release of growth hormone, testosterone and IGF-1 during the night in older healthy men.

Conditions
Sleep
Being tested
Gabapentin, Placebo
Keywords
Delta Sleep, Growth Hormone, IGF-1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GabapentinDrug

    Also called Neurontin

    A single dose Gabapentin 300mg at bedtime.

  • PlaceboDrug

    A single placebo dose with the same physical characteristics of the active intervention.

Study groups in NCT02599701
Study groupRoleWhat they receive
PlaceboPlacebo comparatorA single dose of placebo with exactly the same characteristics of the active drug at bedtime.
Receives: Drug: Placebo
GabapentinExperimentalA single dose of Gabapentin 300mg at bedtime.
Receives: Drug: Gabapentin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Growth Hormone Secretion

    Every 20 minutes after admission to the laboratory, blood samples (2.5 mL) for GH measurement will be collected (between 20:00 - or 2 hours before lights off - and 06:00).

    Measured: During only one sleep night immediately after a single gabapentin or placebo dose at bedtime.

  2. IGF-1

    It will be included in the analysis of the last sample collected for GH, testosterone and cortisol measurements at 06:00.

    Measured: Immediately after the sleep night in that gabapentin or placebo dose were given at bedtime.

Secondary outcomes (5)

  1. Total testosterone

    Every 20 minutes after admission to the laboratory, blood samples (2.5 mL) for free and total testosterone measurements will be collected (between 20:00 - or 2 hours before lights off - and 06:00).

    Measured: During only one sleep night immediately after a single gabapentin or placebo dose at bedtime.

  2. Free testosterone

    Every 20 minutes after admission to the laboratory, blood samples (2.5 mL) for free and total testosterone measurements will be collected (between 20:00 - or 2 hours before lights off - and 06:00).

    Measured: During only one sleep night immediately after a single gabapentin or placebo dose at bedtime.

  3. Cortisol

    Every 20 minutes after admission to the laboratory, blood samples (2.5 mL) for cortisol measurement will be collected (between 20:00 - or 2 hours before lights off - and 06:00).

    Measured: During only one sleep night immediately after a single gabapentin or placebo dose at bedtime.

  4. Apnea-Hypopnea Index during sleep

    Sedative drugs may increase asymptomatic airway collapsability during sleep mainly in older individuals

    Measured: During only one sleep night immediately after a single gabapentin or placebo dose at bedtime. a single gabapentin or placebo dose at bedtime.

  5. Slow Wave Sleep - Stage N3

    Full sleep night polysomnographic recording.

    Measured: During only one sleep night immediately after a single gabapentin or placebo dose at bedtime.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Nov 2015 (estimated)
  2. Study startSep 2015
  3. Primary completionNov 2015
  4. Study completionDec 2015

Why it stopped: Gabapentin increased hypopnea-apnea index in the first 8 recruited subjects.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02599701
Sponsor's protocol ID
AFIP06/2015
Status last verified
Jul 2016
First submitted
21 Jul 2015
Last updated
13 Jul 2016
Results posted
No
Data monitoring committee
No

Publications

  • Giannoulis MG, Martin FC, Nair KS, Umpleby AM, Sonksen P. Hormone replacement therapy and physical function in healthy older men. Time to talk hormones? Endocr Rev. 2012 Jun;33(3):314-77. doi: 10.1210/er.2012-1002. Epub 2012 Mar 20.

    PubMed 22433122

  • Giustina A, Veldhuis JD. Pathophysiology of the neuroregulation of growth hormone secretion in experimental animals and the human. Endocr Rev. 1998 Dec;19(6):717-97. doi: 10.1210/edrv.19.6.0353.

    PubMed 9861545

  • Dattilo M, Antunes HK, Medeiros A, Monico Neto M, Souza HS, Tufik S, de Mello MT. Sleep and muscle recovery: endocrinological and molecular basis for a new and promising hypothesis. Med Hypotheses. 2011 Aug;77(2):220-2. doi: 10.1016/j.mehy.2011.04.017. Epub 2011 May 7.

    PubMed 21550729

  • Penev P, Spiegel K, L'Hermite-Baleriaux M, Schneider R, Van Cauter E. Relationship between REM sleep and testosterone secretion in older men. Ann Endocrinol (Paris). 2003 Apr;64(2):157. No abstract available.

    PubMed 12773954

  • Van Cauter E, Latta F, Nedeltcheva A, Spiegel K, Leproult R, Vandenbril C, Weiss R, Mockel J, Legros JJ, Copinschi G. Reciprocal interactions between the GH axis and sleep. Growth Horm IGF Res. 2004 Jun;14 Suppl A:S10-7. doi: 10.1016/j.ghir.2004.03.006.

    PubMed 15135771

  • Saletu M, Anderer P, Saletu-Zyhlarz GM, Parapatics S, Gruber G, Nia S, Saletu B. Comparative placebo-controlled polysomnographic and psychometric studies on the acute effects of gabapentin versus ropinirole in restless legs syndrome. J Neural Transm (Vienna). 2010 Apr;117(4):463-73. doi: 10.1007/s00702-009-0361-3. Epub 2010 Jan 5.

    PubMed 20049491

  • Foldvary-Schaefer N, De Leon Sanchez I, Karafa M, Mascha E, Dinner D, Morris HH. Gabapentin increases slow-wave sleep in normal adults. Epilepsia. 2002 Dec;43(12):1493-7. doi: 10.1046/j.1528-1157.2002.21002.x.

    PubMed 12460250

  • Rosenberg KP. Gabapentin for chronic insomnia. Am J Addict. 2003 May-Jun;12(3):273-4. No abstract available.

    PubMed 12851024

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Gabapentin in people with Sleep, run by Associação Fundo de Incentivo à Pesquisa at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 13 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Gabapentin increased hypopnea-apnea index in the first 8 recruited subjects.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Growth Hormone Secretion (time frame: During only one sleep night immediately after a single gabapentin or placebo dose at bedtime.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02599701, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2016.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in