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Your Space - Is Sleep Apnea Killing Your Marriage ?
Sleep Apnea or Obstructive Sleep Apnea as it is sometimes called, usually involves loud snoring as one of the symptoms. Anyone that has ever slept with a snoring partner knows that it can be seriously disruptive to one's
According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product
own sleep. But what effect, long term, does it have on a marriage? It is a common situation in many marriages and apparently has more impact than many couples think.
Obviously the experience of sleeping with a loud snor
Obviously the experience of sleeping with a loud snor
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
ng partner is not positive, but what can be done? This is the question that The Sleep Disorders Center at Rush University Medical Center recently set out to ask and hopefully solve. In doing so, they hope to save marriag
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
s that might be in danger of divorce due to this cronic, ongoing struggle to get enough rest at night....and all the interpersonal implications of not achieving a balanced level of sleep.
The Center is currently evaluati
The Center is currently evaluati
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
ng 10 couples in which the male has been diagnosed with obstructive sleep apnea. The couples begin by completing surveys about sleepiness, marriage satisfaction and quality of life. After this step the couples spend the
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
ight in the Center's sleep lab where technicians determine each partner's quantity and quality of sleep.
Two weeks after these tests, and treatment, the couple repeats a night's sleep in the sleep lab for comparison purp
Two weeks after these tests, and treatment, the couple repeats a night's sleep in the sleep lab for comparison purp
ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc
ses. The results have been very interesting and mostly positive.
According to press releases from the Center, the early results show that there is indeed a significant impact on the wife's quality and quantity of sleep.
According to press releases from the Center, the early results show that there is indeed a significant impact on the wife's quality and quantity of sleep.
easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi
It is termed a serious problem that does indeed lead to a hostile and tense situation within the marriage.
In one example cited, the husband's snoring was arousing the wife out of sleep over eight times an hour. Her sle
In one example cited, the husband's snoring was arousing the wife out of sleep over eight times an hour. Her sle
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
p efficiency rating (the percentage of time she was actually asleep) was 73%. The average person's sleep efficiency is closer to 90%.
In this example, the wife had attempted to use ear plugs, earphones and had finally gi
In this example, the wife had attempted to use ear plugs, earphones and had finally gi
and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ
en up and started to sleep alone.
To treat the husband, the Center used a device known as a continuous positive airway pressure machine (CPAP). This machine is non-invasive and the flow of air it delivers prevents the up
To treat the husband, the Center used a device known as a continuous positive airway pressure machine (CPAP). This machine is non-invasive and the flow of air it delivers prevents the up
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
er airway from collapsing during sleep, allowing the lungs to perform normally.
In this particular case, the wife's quality of life measure jumped from a 1.2 to a 7.0, indicating that the snoring had been alleviated and
In this particular case, the wife's quality of life measure jumped from a 1.2 to a 7.0, indicating that the snoring had been alleviated and
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
was no longer significantly bothering her. Her sleepiness scale (how tired she felt) dropped from 12 to a 6. Marital Satisfaction scores improved from a 3 to 5.8 and the wife's sleep efficiency moved up from 73% to 82%.
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
Obviously on every level, this treatment had made great strides for the couple and showed promise in other situations.
The Rush Center is continuing tests expected to be completed in April 2006. The Center will evaluate
The Rush Center is continuing tests expected to be completed in April 2006. The Center will evaluate
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
he results and expand on the information being provided to the public.
Their press release is very specific about the measures taken as each couple enters the program. As stated "...both the husband and wife undergo simu
Their press release is very specific about the measures taken as each couple enters the program. As stated "...both the husband and wife undergo simu
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
ltaneous polysomonography, a sleep test that monitors brain activity, eye movements, muscle activity, heart rate and rhythms, breathing patterns, blood oxygen level and body movements and respiratory sounds. All sensors a
t?
As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel
As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel
e noninvasive and do not cause pain or discomfort.
The study involves first diagnosing the sleep apnea. The husband will sleep alone in the center as technicians monitor his sleep. If he has sufficient sleep apnea, he wi
The study involves first diagnosing the sleep apnea. The husband will sleep alone in the center as technicians monitor his sleep. If he has sufficient sleep apnea, he wi
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
l undergo a split night study to determine the appropriate CPAP treatment.
Sleep apnea is a serious health problem that should be treated. Obstructive sleep apnea occurs when the tissue in the back of the throat collapse
Sleep apnea is a serious health problem that should be treated. Obstructive sleep apnea occurs when the tissue in the back of the throat collapse
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
s and blocks the airway. The breathing pause lasts at least 10 seconds and can occur 10 or more times an hour. Apnea lowers the oxygen level in the blood leaving the patient vulnerable to hypertension, stroke and other ca
.
As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de
As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de
diovascular problems.
Obstructive sleep apnea can occur in men and women of any age; however, it is most common in obese, middle-aged men. The most common signs of sleep apnea are loud snoring, choking or gasping during
Obstructive sleep apnea can occur in men and women of any age; however, it is most common in obese, middle-aged men. The most common signs of sleep apnea are loud snoring, choking or gasping during
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
leep, and fighting sleepiness during the day. In addition to continuous positive airway pressure, treatment includes losing weight, sleeping on your side instead of your back, avoiding alcohol and tobacco."
copyright 200
copyright 200
tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products
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