Research

Active Studies

Narcolepsy Studies

  1. Axsome (AXS 301/302)- A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of AXS-12 in the Treatment of Cataplexy and Excessive Daytime Sleepiness in Subjects with Narcolepsy
    1. Ages 15-75
    2. Has a primary diagnosis of narcolepsy with cataplexy. The diagnosis must be based on ICSD-3 criteria, with PSG and MSLT performed and documented in the 10 years before Baseline.
    3. Current continuing presence of EDS as defined by subject report for the last 3 months and an ESS > 10 at Screening and Baseline.
    4. At least 7 cataplexy attacks per week (or  >14 across two weeks), as recorded in the subject’s Sleep and Symptom Daily Diary during the screening period.
    5. Body mass index between from 18 to <45 kg/m2
    6. Concurrent use of any of the following medications: oxybate salt (in any formulation), solriamfetol, pitolisant, atomoxetine, stimulants (other than modafinil/armodafinil), anticonvulsants, clonidine, SSRIs, SNRIs, DNRIs, MAOIs, TCAs, hypnotics, anxiolytics, sedating antihistamines, antipsychotics, or any other experimental medications designed to treat narcolepsy, cataplexy or any other condition.
  2. Jazz (JZP258-406)- An open-label, multicenter switch study evaluating changes in blood pressure in participants. Switching from high-sodium oxybate to Xywav
    1. Diagnoses of Narcolepsy
    2. 11 weeks with about 8 visits
  3. Jazz (JZP258-407)-A Prospective, open-label, single-arm, multicenter study to evaluate the effect of low-sodium oral solution (Xywav) on sleepiness, polysomnography, and functional outcomes in adult participants
    1. Ages 18-75
    2. Diagnoses of Idiopathic Hypersomnia or Narcolepsy
    3. 10-21 weeks
  4. Jazz (JZP258-407)-Narcolepsy greater than 9-gram cohort- A Prospective, open-label, single-arm, multicenter study to evaluate the effect of low-sodium oral solution (Xywav) on sleepiness, polysomnography, and functional outcomes in adult participants
    1. Ages 18-75
    2. Diagnoses of Narcolepsy
    3. 10-36 weeks
  5. Merck (MK-6552-004)- A Two-Part Study to Assess the Safety, Tolerability, Pharmacokinetics and Sleep Latency Effects of MK-6552 in Participants with Narcolepsy Type 1
    1. Is an individual of any sex/gender, from 18 years to 55 years of age inclusive, at the time of providing the informed consent
    2. Has regular sleep initiation times no later than midnight.
    3. Has a BMI between 18 and 32 kg/m2, inclusive. See Section 8.3.3 for criteria on rounding to the nearest whole number. BMI = weight (kg)/height (m)2. Note: Participants who have a BMI up to 35.0 kg/m2 may be enrolled at the discretion of the investigator.

Idiopathic Hypersomnia Studies

  1. Jazz (JZP258-407)-A Prospective, open-label, single-arm, multicenter study to evaluate the effect of low-sodium oral solution (Xywav) on sleepiness, polysomnography, and functional outcomes in adult participants
    1. Ages 18-75
    2. Diagnoses of Idiopathic Hypersomnia or Narcolepsy

Obstructive Sleep Apnea Studies

  1. Liva Nova- Treating Obstructive Sleep Apnea using Targeted Hypoglossal Neurostimulation
    1. 18 years of age
    2. Non-compliant with CPAP/APAP/BiPAP or failed therapy (must agree to not use any therapy while in the trial, even if they are placed in the control group).
    3. No other diagnosed sleep disorders.
    4. No other implanted devices including a Pacemaker.
    5. BMI < 35 kg/m^2

Insomnia

  1. Bayer- A randomized, parallel-group treatment, Phase 2, double-blind pilot study to investigate the efficacy and safety of elinzanetant compared with placebo for treatment of sleep disturbances associated with menopause.
    1. Females aged 40 to 65 years, inclusive, at signing of informed consent.
    2. BMI between 18 and 38 kg/m2 at screening.
    3. The participants self reported time in bed between 6 and 9 hours.

Lung Studies

  1. Sanofi COPD (EFC16750)- Randomized, double-blind, placebo-controlled, parallel-group Phase 3 study to evaluate the efficacy, safety, and tolerability of SAR440340/REGN3500/itepekimab (anti-IL-33 mAb) in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD)
    1. 40-85
    2. Participants with a physician diagnosis of COPD for at least 1 year (based on GOLD definition).
    3. Participants with a smoking history of > 10 pack-years, but who are not currently smoking, and smoking cessation much have occurred > 6 months prior to Screening (Visit 1A) with an intention to quit permanently.
    4. Moderate to severe exacerbations within the last year.
    5. Participants with SoC controller therapy, for > 3 months prior to Screening (Visit 1A) and at a stable dose of controller therapy for at least 1 month prior to the screening AND during the screening period, including either:
      • Double Therapy: ICS+LABA or LAMA+LABA
      • Triple Therapy: LAMA+LABA+ICS
  2. Sanofi Asthma (LPS16676)- A randomized, double-blind, placebo-controlled study assessing the long-term effect of dupilumab on prevention of lung function decline in patients with uncontrolled moderate to severe asthma.
    1. Must be 18
    2. Diagnosed with asthma for > 1 year
    3. History of > 1 severe exacerbation within the last year
    4. No steroids within the last 1 month prior to Screening visit
  3. Chiesi COPD (CLI-05993AA3-06)-A phase III, 52-week, multinational, multicenter, randomized, double-blind, 2-arm parallel group study comparing efficacy, safety and tolerability of the fixed dose triple combination of beclomethasone dipropionate plus formoterol fumarate plus glycopyrronium bromide (CHF 5993) with the fixed dose duel combination of beclomethasone dipropionate plus formoterol fumarate (CHF 535), both administered via pMDI.
    1. Primary diagnosis of COPD
    2. Male or female >40 years
    3. COPD diagnosis for at least 12 months before screening with the definition by the GOLD report
    4. Current or ex-smokers who quit at least 6 months prior to screening with a smoking history of at least 10 pack-years
    5. Use of daily inhaled therapy and stable for at least 3 months

Other Studies

  1. Idorsia (ID-078A205)- Multi-center, double-blind, randomized, placebo-controlled, parallel-group, polysomnography, dose-finding study assessing the efficacy, safety, and pharmacokinetics of multiple-dose oral administration of daridorexant in pediatric subjects aged 10 to < 18 years with insomnia disorder
    1. Ages 10-18
    2. Weight > 55lbs
    3. Does not nap more than 1 hour, 3 weekdays per week during the 3 months prior to screening.

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